Recall Z-1257-2021— Cordis Corporation
Class I · Completed
Class I FDA medical device recall by Cordis Corporation, initiated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC. Reason: Distal tip may become separated from the lumen wire in specific lots..
- Recalling firm
- Cordis Corporation
- Classification
- Class I
- Status
- Completed
- Initiated
- 2021-02-11
- Firm location
- Miami Lakes, FL, United States
Product description
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
Reason for recall
Distal tip may become separated from the lumen wire in specific lots.
Data sourced from openFDA. This site is unofficial and independent of the FDA.