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.

• 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
• DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
  FDA Device · Class II · 2021-09-08 · Cardiovascular Systems
• 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
• 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
• 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
• 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
• 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
• 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
• ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18
  FDA Device · Class II · 2017-04-19 · Cardiovascular Systems
• 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
• ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only
  FDA Device · Class II · 2016-07-06 · Cardiovascular Systems
• Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125
  FDA Device · Class I · 2015-04-01 · Cardiovascular Systems
• 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
• 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
• 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