Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0915-2022)

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 Floppy

Product Classification:

Class II

Date Initiated: March 8, 2022

Date Posted: April 20, 2022

Recall Number: Z-0915-2022

Event ID: 89753

Reason for Recall:

Pouch seals may be open, compromising sterility.

Status: Ongoing

Product Quantity: 433 5-packs

Code Information:

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

Distribution Pattern:

Distribution in the US and territories, Japan, and Canada

Voluntary or Mandated:

Voluntary: Firm initiated