Boston Scientific JAGTOME REVOLUTION RX 39-20-450-025 Sterility Risk Recall

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Recalling firmBoston Scientific Corporation100 Boston Scientific Way, N/A · Marlborough, MA 01752-1234

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling a specific model of JAGTOME REVOLUTION RX device because a sterile barrier breach could compromise sterility. This means the device might not be safe for medical use, potentially leading to infections.

Why it’s dangerous

The device has a breach in its sterile barrier, which means it could be contaminated during use. This contamination risk could lead to infections in patients during medical procedures.

Who’s affected

Medical professionals using the JAGTOME REVOLUTION RX device with the specified lot numbers and material code are affected. Patients receiving procedures with this device face the highest risk of infection.

How to tell if you have this one

Check for the model number JAGTOME REVOLUTION RX 39-20-450-025 and material number M00584250. Affected units have lot numbers starting with 27482864 and GTIN 8714729953241.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model number, material number, lot number, and GTIN to confirm if your device is affected.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall states the sterile barrier is compromised, so it is not safe for medical use. Affected units should not be used.

What should I do if I have this device?

Check the model number and lot number to see if it's affected. If it is, contact Boston Scientific for instructions.

How can I tell if my device is affected?

Look for the model number JAGTOME REVOLUTION RX 39-20-450-025, material number M00584250, lot number 27482864, and GTIN 8714729953241.

Take action

Contact Boston Scientific

We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0766-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0766-2022 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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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-0766-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0766-2022 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.

Boston Scientific Corporation recalls JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250

Recall notice