Boston Scientific Corporation ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
Products Sold
ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
Boston Scientific Corporation is recalling ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy due to Pouch seals may be open, compromising sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pouch seals may be open, compromising sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026