Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0916-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Product Classification:

Class II

Date Initiated: March 8, 2022

Date Posted: April 20, 2022

Recall Number: Z-0916-2022

Event ID: 89753

Reason for Recall:

Pouch seals may be open, compromising sterility.

Status: Ongoing

Product Quantity: 488 5-packs

Code Information:

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

Distribution Pattern:

Distribution in the US and territories, Japan, and Canada

Voluntary or Mandated:

Voluntary: Firm initiated