DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
This recall has been completed (originally issued July 21, 2021).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- July 21, 2021
- Recall Number
- Z-2385-2021
- Quantity
- 8 units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Lot / Code Info
Lot 340925
Root Cause
Process control
Action Taken
The firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.
More recalls by Cardiovascular Systems Inc
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Mod...
Dec 21, 2021
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Jul 21, 2021
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Nu...
Apr 13, 2018