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RotaWire Drive and wireClip Torquer recallZ-0916-2022 · Boston Scientific Corporation · initiated Mar 8, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Pouch seals may be open, compromising sterility.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0916-2022
Status
Open, Classified
Initiated by the company
Mar 8, 2022
Recalling firm
Boston Scientific Corporation
Quantity
488 5-packs
Product code
MCX
FDA submissions
P900056
Distribution
Distribution in the US and territories, Japan, and Canada

Product description

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

32 devices cleared under P900056 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89753).

Sources and updates

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