Home / Recalls / Cardiovascular Systems, Inc. / Z-1290-2015

Z-1290-2015 Class I Terminated

Recalled by Cardiovascular Systems, Inc. — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
April 1, 2015
Initiation Date
March 4, 2015
Termination Date
April 26, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30

Product Description

Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Reason for Recall

The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.

Distribution Pattern

Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.

Code Information

107046, 106992, 106993, 106990.

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-2386-2021 Class II — STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, RE (July 21, 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-0506-2018 Class II — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-0505-2018 Class II — Peripheral Diamondback 1.25 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)