FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
- Recall number
- Z-0381-2022
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
- Status
- Terminated
- Initiated
- 2021-11-08
- Posted
- not on file
- Terminated
- 2023-05-02
- Reason
- Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 7 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
- Lot, serial or model codes
- US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28