Boston Scientific Corporation Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076, EU Serial number RP005010, GTIN 08714729975151.
Products Sold
US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
Boston Scientific Corporation is recalling Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) an due to Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Recommended Action
Per FDA guidance
The 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026