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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific ROTAPRO

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 Class 2 Device Recall Boston Scientific ROTAPROsee related information
Date Initiated by FirmNovember 08, 2021
Create DateDecember 15, 2021
Recall Status1 Terminated 3 on May 02, 2023
Recall NumberZ-0381-2022
Recall Event ID 89034
Product Classification Catheter, coronary, atherectomy - Product Code MCX
ProductBoston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Code Information US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactMs. Rebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
FDA Determined
Cause 2		Employee error
ActionThe recalling firm issued letters dated 11/8/2021 on the same date and flagged "Urgent Medical Device Removal - Immediate Action Required." It explains the reason for recall, the risk to health, and provides removal instructions. The instructions say to immediately discontinue use of and segregate the affected product. A Reply Verification Tracking Form is enclosed for immediate completion and return. The customer will be contacted by BSC and provided a Returned Goods Authorization for return of the device.
Quantity in Commerce7 devices
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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