CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Rotawire Drive and wireClip Torquer, Rotawire Drive Floppy recalled

Boston Scientific is recalling Rotawire Drive and wireClip Torquer, Rotawire Drive Floppy. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesROTAWIRE 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

Quantity recalled433 5-packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0915-2022
FDA event ID: 89753
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class II
Status: Ongoing
Recall initiated: 8 Mar 2022
FDA classified: 12 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Mar 2022	Recall initiated by company
12 Apr 2022	Classified by FDA	+35 days
20 Apr 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Pouch seals may be open, compromising sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

Where it was distributed

Distribution in the US and territories, Japan, and Canada

Questions about this recall

Is Rotawire Drive and wireClip Torquer, Rotawire Drive Floppy recalled?

Yes. Boston Scientific recalled Rotawire Drive and wireClip Torquer, Rotawire Drive Floppy on 8 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-0915-2022.

Why was it recalled?

Pouch seals may be open, compromising sterility.

Which lots are affected?

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

Where was it sold?

Distribution in the US and territories, Japan, and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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