Recall Z-0915-2022 ยท MCX Catheter, Coronary, Atherectomy
Boston Scientific Corporation
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
| Date | Mar 8, 2022 |
| Status | Open, Classified |
| Reason | Pouch seals may be open, compromising sterility. |
| Root cause | Process control |
| Action | US consignees were mailed an overnight delivery of the customer letter. OUS consignees will be contacted by letter delivery or email. Accounts are asked to return any unused affected devices to the recalling firm. The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions. |
| Quantity | 433 5-packs |
| Distribution | Distribution in the US and territories, Japan, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.