Boston Scientific recalls JAGTOME REVOLUTION RX 39-20-260-025 with material number M00584240 due to sterile barrier breach. Affected units have specific lot numbers. Consumers should contact for details.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling a specific model of medical device because a sterile barrier was compromised, which could lead to contamination. This recall affects certain lot numbers of the JAGTOME REVOLUTION RX 39-20-260-025 device.
The device's sterile barrier has been breached, meaning it may not be sterile when used. This could lead to infections or contamination during medical procedures if the device is not properly sterilized.
Medical professionals and patients using the JAGTOME REVOLUTION RX 39-20-260-025 device with the listed lot numbers are affected. Those who have the device and are at risk of infection due to compromised sterility are most vulnerable.
Check the device's material number (M00584240) and lot numbers listed: 27481920, 27524107, 27525279, 27530542, 27574053, 27598798, 27652479, 27722062, 27722511, 27742261, 27758891, 27795634, 27846706, 27897451, 27969768, 28027118, 28070708.
Identify the material number (M00584240) and lot numbers to confirm if your device is affected.
The JAGTOME REVOLUTION RX 39-20-260-025 with material number M00584240.
Lot numbers: 27481920, 27524107, 27525279, 27530542, 27574053, 27598798, 27652479, 27722062, 27722511, 27742261, 27758891, 27795634, 27846706, 27897451, 27969768, 28027118, 28070708.
The recall record does not specify a remedy, so contact Boston Scientific directly for instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0765-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0765-2022 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.
