Lower risk Medical device recall · FDA · Published November 8, 2021

Boston Scientific ROTAPRO Console Recall: Missing Retest Instructions

Boston Scientific recalls ROTAPRO console models H74939309010 (US) and H74939309030 (EU) due to missing retest instructions for pneumatic kits. Affected units include specific US and EU serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0381-2022Medical device Boston Scientific ›

Lower-risk recall

Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

Take action

Contact the company

Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling certain ROTAPRO console models because their manufacturing instructions didn't include warnings about not retesting pneumatic kits after failure. This could lead to improper use if users attempt retesting. Read more at govinfonow.com/recall/61560-boston-scientific-rotapro-console-recall-missing-retest-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/61560-boston-scientific-rotapro-console-recall-missing-retest-instructions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0381-2022

Cite this page

“Boston Scientific ROTAPRO Console Recall: Missing Retest Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61560-boston-scientific-rotapro-console-recall-missing-retest-instructions. Based on FDA recall #Z-0381-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0381-2022%22&limit=1).

The FDA announced on 2021-11-08 that Boston Scientific Corporation voluntarily recalled its ROTAPRO Rotational Atherectomy System Consoles due to a manufacturing nonconformity involving missing instructions for pneumatic kit retesting. The agency issued recall number Z-0381-2022 for the Class II device.

How to tell if you have it

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model H74939309010 (US)
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model H74939309030 (EU)
US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040
EU Serial number RP005010
GTIN 08714729975076
GTIN 08714729975151

The hazard

According to the FDA, manufacturing instructions for the console did not include directions to not retest the pneumatic kit component upon failure. This omission constitutes an internal nonconformity in the production process.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Recent brand recalls include the Boston Scientific Imager II Angiographic Catheters Recall dated 2026-08-24 for tip fracture risk and the Boston Scientific LUX-Dx Cardiac Monitor System Recall dated 2026-08-06 for delayed AF burden alerts. Other recent recalls of similar products include the Boston Scientific StoneSmart Connect Console Power Adapters recall (2026-07-22), the Boston Scientific CSK Electrodes Recall (2026-04-29), the Medline Spinal Block Kits Recall (2026-04-10), and the American Contract Systems Convenience Kit Recall (2026-06-29).

How to tell if you have this one

Check for US model numbers H74939309010 or EU model numbers H74939309030. Look for US serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, RP005040 or EU serial number RP005010.

Brand
Boston Scientific
Product
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU)
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Console Model
Identify your console model number from the product label to see if it matches the recalled models H74939309010 (US) or H74939309030 (EU).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Nevada, New York, Ohio, Pennsylvania, Washington.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Nov 8, 2021Firm started the recall
Dec 15, 2021FDA classified it Class II
Dec 22, 2021Published in FDA’s Enforcement Report
May 2, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61560-boston-scientific-rotapro-console-recall-missing-retest-instructions">Boston Scientific ROTAPRO Console Recall: Missing Retest Instructions (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0381-2022 (November 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0381-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.