Cardiovascular Systems Inc recalls

12 recalls on record · latest: November 22, 2021

Official U.S. recall history for Cardiovascular Systems Inc, compiled from official government records.

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Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

November 22, 2021 · Medical device recalls High risk Under certain circumstances, the WIRION filter assembly may become difficult to…

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM recalled over labeling errors

July 21, 2021 · Medical device recalls Moderate risk There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs…

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM recalled over labeling errors

July 21, 2021 · Medical device recalls Moderate risk There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs…

Cardiovascular Systems Inc recalls CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Prod…

April 13, 2018 · Medical device recalls Moderate risk The pumps may switch to stand-by during use requiring the pump to be reset prio…

Cardiovascular Systems Inc recalls Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patien…

September 14, 2017 · Medical device recalls Moderate risk Cardiovascular Systems, Inc. (CSI) is removing the products because it was iden…

Cardiovascular Systems Inc recalls Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patien…

September 14, 2017 · Medical device recalls Moderate risk Cardiovascular Systems, Inc. (CSI) is removing the products because it was iden…

Cardiovascular Systems Inc recalls CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

April 14, 2017 · Medical device recalls Moderate risk Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10…

Cardiovascular Systems Inc recalls ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide…

March 3, 2017 · Medical device recalls Moderate risk Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Fle…

Cardiovascular Systems Inc recalls ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Pr…

February 9, 2017 · Medical device recalls Moderate risk CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERE…

Cardiovascular Systems Inc recalls DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimal…

December 7, 2016 · Medical device recalls Moderate risk CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

Cardiovascular Systems Inc recalls ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VP…

June 13, 2016 · Medical device recalls Moderate risk The pouch label was missing the use by date (UBD) of 2018-04.

Cardiovascular Systems, Inc. recalls Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate sten…

March 4, 2015 · Medical device recalls High risk The OAD saline sheath outer layer may flake off from the catheter due to fricti…