Z-2386-2021 Class II Terminated
FDA device recall Z-2386-2021 was initiated by Cardiovascular Systems Inc on July 21, 2021 and is designated Class II. 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. The recall status is terminated (terminated March 18, 2026). Affected quantity: 8 units.
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