Maquet Medical Systems Usa recalls
Maquet Medical Systems Usa appears in 41 official U.S. recall notices indexed by RecallRadar, most recently on 2024-05-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 41 |
|---|---|
| Published | 2012-08-08 to 2024-05-22 |
| By agency | FDA Device (41) |
| By classification | Class II (39), Class I (1), Class III (1) |
| By status | ongoing (35), terminated (6) |
| Distribution named in notices | AL, AZ, CA, CO, FL, GA, IA, IL, KS, MI, MN, MO, NC, NE, OH, PA, TX, US, WA, WI |
Recalls
- CARDIOHELP-i System
FDA Device · Class II · 2024-05-22 · Maquet Medical Systems Usa
Reason: The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. - Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa
Reason: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. - BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa
Reason: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. - Bubble Sensor (REF: 70105.5720)
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
Reason: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device. - BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
Reason: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inf… - BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
Reason: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inf… - Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
FDA Device · Class II · 2023-12-27 · Maquet Medical Systems Usa
Reason: Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be e… - CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal b…
FDA Device · Class III · 2023-12-27 · Maquet Medical Systems Usa
Reason: CARDIOHELP-i System was not properly tested to measure leakage current - CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal…
FDA Device · Class II · 2023-12-20 · Maquet Medical Systems Usa
Reason: Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Mi… - CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205
FDA Device · Class I · 2023-12-13 · Maquet Medical Systems Usa
Reason: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hyp… - Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
FDA Device · Class II · 2023-11-15 · Maquet Medical Systems Usa
Reason: It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual f… - QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromis… - QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,… - BEQ-HLS 5050 USA
FDA Device · Class II · 2023-03-08 · Maquet Medical Systems Usa
Reason: Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia. - BEQ-HLS 7050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa
Reason: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). - BEQ-HLS 5050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa
Reason: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). - BEQ-HLS 7050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa
Reason: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). - BEQ-HLS 5050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa
Reason: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). - Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood…
FDA Device · Class II · 2022-04-13 · Maquet Medical Systems Usa
Reason: Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly,… - Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers…
FDA Device · Class II · 2021-08-04 · Maquet Medical Systems Usa
Reason: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species. - Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface imm…
FDA Device · Class II · 2016-11-16 · Maquet Medical Systems Usa
Reason: Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail. - TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operatin…
FDA Device · Class II · 2015-01-28 · Maquet Medical Systems Usa
Reason: The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table syste… - Maquet PowerLED 700
FDA Device · Class II · 2014-06-18 · Maquet Medical Systems Usa
Reason: Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach. - MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany
FDA Device · Class II · 2013-11-06 · Maquet Medical Systems Usa
Reason: It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when… - Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) ser…
FDA Device · Class II · 2012-08-08 · Maquet Medical Systems Usa
Reason: As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February…