Maquet Cardiovascular Us Sales recalls

Maquet Cardiovascular Us Sales appears in 62 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating
  FDA Device · Class II · 2014-12-31 · Maquet Cardiovascular Us Sales
  Reason: Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bi…
• Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal byp…
  FDA Device · Class II · 2014-11-19 · Maquet Cardiovascular Us Sales
  Reason: Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
• MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and main…
  FDA Device · Class II · 2014-03-19 · Maquet Cardiovascular Us Sales
  Reason: The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a…
• Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet t…
  FDA Device · Class II · 2014-02-05 · Maquet Cardiovascular Us Sales
  Reason: Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
• TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg…
  FDA Device · Class II · 2013-10-02 · Maquet Cardiovascular Us Sales
  Reason: MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.
• QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
  FDA Device · Class II · 2013-10-02 · Maquet Cardiovascular Us Sales
  Reason: The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the in…
• MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05
  FDA Device · Class II · 2013-07-10 · Maquet Cardiovascular Us Sales
  Reason: MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By ful…
• MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extra…
  FDA Device · Class II · 2013-07-03 · Maquet Cardiovascular Us Sales
  Reason: The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
• Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180)
  FDA Device · Class I · 2013-05-08 · Maquet Cardiovascular Us Sales
  Reason: When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
• Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants
  FDA Device · Class II · 2013-02-27 · Maquet Cardiovascular Us Sales
  Reason: ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
• QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
  FDA Device · Class II · 2012-11-07 · Maquet Cardiovascular Us Sales
  Reason: It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shippe…
• FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients…
  FDA Device · Class I · 2012-07-18 · Maquet Cardiovascular Us Sales
  Reason: A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "…