Home / Recalls / Cardiovascular Systems Inc / Z-2386-2021

Z-2386-2021 Class II Terminated

Recalled by Cardiovascular Systems Inc — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
July 21, 2021
Termination Date
March 18, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units

Product Description

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

Code Information

Lot 340931

Other recalls by Cardiovascular Systems Inc

  • Z-0394-2022 Class I — WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Cat (November 22, 2021)
  • Z-2385-2021 Class II — DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, (July 21, 2021)
  • Z-3021-2018 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 13, 2018)
  • Z-0505-2018 Class II — Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-0506-2018 Class II — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-2122-2017 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 14, 2017)
  • Z-1771-2017 Class II — ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. S (March 3, 2017)
  • Z-1877-2017 Class II — ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7 (February 9, 2017)
  • Z-1230-2017 Class II — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbit (December 7, 2016)
  • Z-2051-2016 Class II — ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only (June 13, 2016)