FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Recall number
- Z-0916-2022
- Recalling firm
- Boston Scientific Corporation
- Product
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Status
- Open, Classified
- Initiated
- 2022-03-08
- Posted
- not on file
- Terminated
- not on file
- 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
- 488 5-packs
- Distribution
- Distribution in the US and territories, Japan, and Canada
- Lot, serial or model codes
- ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231
- 510(k) numbers
- not on file
- PMA numbers
- ["P900056"]
- Product code
- MCX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28