Z-0381-2022Class II

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and...

Name: Z-0381-2022 Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and...
Creator: Boston Scientific Corporation
Published: 2021-11-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-11-08 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU) on 2021-11-08. FDA classified it as Class II and gives the reason as "Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0381-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-08
Posted: 2021-12-15
Terminated: 2023-05-02
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Product code: MCX Catheter, Coronary, Atherectomy
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 7 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Product codes and lots: US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0381-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0381-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-15

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)