Z-0916-2022Class II

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Name: Z-0916-2022 ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Creator: Boston Scientific Corporation
Published: 2022-03-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-03-08 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support on 2022-03-08. FDA classified it as Class II and gives the reason as "Pouch seals may be open, compromising sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0916-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-08
Posted: 2022-04-12
Recalling firm: Boston Scientific Corporation
Product: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Product code: MCX Catheter, Coronary, Atherectomy
Reason for recall: Pouch seals may be open, compromising sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 488 5-packs
Distribution: Distribution in the US and territories, Japan, and Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0915-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-12
Z-0916-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-12

Product code MCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)