Boston Scientific recalls ROTAWIRE Drive and wireClip Torquer devices due to pouch seals potentially compromising sterility. Affected units include specific batch numbers and model labels.
Pouch seals may be open, compromising sterility.
Boston Scientific is recalling ROTAWIRE Drive and wireClip Torquer devices because pouch seals might be open, which could compromise sterility. This means the devices might not be sterile when used, posing a risk of infection during medical procedures.
The pouch seals on these devices may be open, which can compromise sterility. If the devices are not sterile, they could cause infections during medical procedures. This is a risk during surgical or medical treatments.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices could face infection if the devices are not sterile.
Check for the product labels: ROTAWIRE Drive Floppy (5-pack) with UPN H74939462005 or individual units labeled as Single with UPN H74939462001. Also look for batch numbers 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019, 27756205, 27756933, and 27756935.
Look for product labels indicating ROTAWIRE Drive Floppy (5-pack) with UPN H74939462005 or individual units labeled as Single with UPN H74939462001.
The pouch seals on these devices may be open, which can compromise sterility. This could lead to infections during medical procedures.
Affected batch numbers include 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019, 27756205, 27756933, and 27756935.
Check for the product labels: ROTAWIRE Drive Floppy (5-pack) with UPN H74939462005 or individual units labeled as Single with UPN H74939462001.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0915-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0915-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
