Cardiovascular Systems recalls
Cardiovascular Systems appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2021-12-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 15 |
|---|---|
| Published | 2012-07-18 to 2021-12-29 |
| By agency | FDA Device (15) |
| By classification | Class II (11), Class I (3), Class III (1) |
| By status | terminated (15) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
FDA Device · Class I · 2021-12-29 · Cardiovascular Systems
Reason: Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating… - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems
Reason: There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems
Reason: There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2018-09-19 · Cardiovascular Systems
Reason: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. - Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems
Reason: Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. - Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems
Reason: Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2017-05-31 · Cardiovascular Systems
Reason: Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand… - ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14
FDA Device · Class II · 2017-05-03 · Cardiovascular Systems
Reason: CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with F… - ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18
FDA Device · Class II · 2017-04-19 · Cardiovascular Systems
Reason: Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flext… - DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cathete…
FDA Device · Class II · 2017-03-01 · Cardiovascular Systems
Reason: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. - ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only
FDA Device · Class II · 2016-07-06 · Cardiovascular Systems
Reason: The pouch label was missing the use by date (UBD) of 2018-04. - Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125
FDA Device · Class I · 2015-04-01 · Cardiovascular Systems
Reason: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large en… - CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003
FDA Device · Class I · 2014-08-20 · Cardiovascular Systems
Reason: CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use. - CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicate…
FDA Device · Class III · 2014-03-05 · Cardiovascular Systems
Reason: Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in… - CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide
FDA Device · Class II · 2012-07-18 · Cardiovascular Systems
Reason: CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the…