Cardiovascular Systems Inc
Saint Paul, MN
This page shows every FDA and USDA recall linked to Cardiovascular Systems Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
15
Total Recalls
2012
First Recall
2021
Most Recent
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number)...
Dec 21, 2021
· Device
Terminated
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Jul 21, 2021
· Device
Completed
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Jul 21, 2021
· Device
Completed
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-...
Apr 13, 2018
· Device
Terminated
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy...
Sep 14, 2017
· Device
Terminated
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy...
Sep 14, 2017
· Device
Terminated
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-...
Apr 14, 2017
· Device
Terminated
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW...
Apr 10, 2017
· Device
Terminated
ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide....
Mar 3, 2017
· Device
Terminated
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145
Peripheral Orbital Atherectomy System (OAS) is...
Feb 22, 2017
· Device
Terminated
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model...
Jun 13, 2016
· Device
Terminated
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125.
The system is indicated to facil...
Mar 20, 2015
· Device
Terminated
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125M...
Aug 14, 2014
· Device
Terminated
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125
Product...
Feb 26, 2014
· Device
Terminated
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. St...
Jul 9, 2012
· Device
Terminated