Boston Scientific recalls EXALT Model D Single-Use Duodenoscope (Box : M00542421) due to perforation risk during use. Learn if you have the device and what to do.
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes (Box 2) because they can cause perforation in the digestive tract during procedures. This risk is serious and requires immediate attention from medical users.
The device can cause perforation (a hole) in the digestive tract during insertion, advancement, or removal. This risk is highlighted in the updated instructions for use as a known hazard during medical procedures.
Medical professionals who use the EXALT Model D Single-Use Duodenoscope for procedures are most at risk. Patients undergoing procedures with this device could also be affected.
Check for the EXALT Model D Single-Use Duodenoscope (Box 2) with UPN: M00542421. The device is intended for sterile, single-use procedures with the EXALT Controller.
Immediately stop using the EXALT Model D Single-Use Duodenoscope (Box 2) with UPN: M00542421 if you have it.
No, the device can cause perforation in the digestive tract during procedures, so it should not be used.
Check for the EXALT Model D Single-Use Duodenoscope (Box 2) with UPN: M00542421. The device is intended for sterile, single-use procedures with the EXALT Controller.
Immediately stop using it and contact Boston Scientific for further 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-1080-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1080-2022 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.
