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.
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
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.
The console's instructions didn't specify that pneumatic kits shouldn't be retested after failure. Retesting could cause improper function, potentially leading to complications during vascular procedures.
Medical professionals using the ROTAPRO console for vascular procedures are most at risk. Patients receiving these procedures may be affected if the console is used incorrectly.
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.
Identify your console model number from the product label to see if it matches the recalled models H74939309010 (US) or H74939309030 (EU).
The recall is for a missing instruction about not retesting pneumatic kits after failure. It's a low-risk issue that could lead to improper use if users attempt retesting.
Check for US model numbers H74939309010 or EU model numbers H74939309030, and US serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, RP005040 or EU serial number RP005010.
The recall doesn't specify a remedy, so Boston Scientific has not provided instructions for action. Check with the manufacturer for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0381-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0381-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
