Recalls / —

—#192364

Product

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

FDA product code

MCX — Catheter, Coronary, Atherectomy

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P900056

Affected lot / code info

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

Why it was recalled

Pouch seals may be open, compromising sterility.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern

Distribution in the US and territories, Japan, and Canada

Timeline

Recall initiated

2022-03-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.