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U.S. Department of Health and Human Services

Class 2 Device Recall ROTAWIRE

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  Class 2 Device Recall ROTAWIRE see related information
Date Initiated by Firm March 08, 2022
Create Date April 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0916-2022
Recall Event ID 89753
PMA Number P900056 
Product Classification Catheter, coronary, atherectomy - Product Code MCX
Product ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca Kinkead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Pouch seals may be open, compromising sterility.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MCX and Original Applicant = Boston Scientific Corp.
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