Brand

Cardiovascular Systems, Inc. Recalls

8 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Cardiovascular Systems, Inc..

8Total Recalls
1Critical
2,090Units Affected
Apr 13, 2018Most Recent
All Recalls

Every Cardiovascular Systems, Inc. Recall

Sorted by most recent. Click any recall for full details.

8 recalls
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Us...
Medical Implants·18 affected·Apr 13, 2018
High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Medical Devices·1,396 affected·Apr 14, 2017
High RiskFDA
Cardiovascular Systems Inc
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: ...
Medical Devices·595 affected·Feb 9, 2017
High RiskFDA
Cardiovascular Systems Inc
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cath...
Surgical Devices·8 affected·Dec 7, 2016
CriticalFDA
Cardiovascular Systems, Inc.
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in p...
Medical Implants·30 affected·Mar 4, 2015
High RiskFDA
Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxid...
Medical Devices·27 affected·Jun 18, 2012