Boston Scientific recalls EXALT Model D Single-Use Duodenoscope (Box 1) due to perforation risk during procedures. 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 because they can cause perforation during medical procedures. This risk affects patients undergoing endoscopic exams or surgeries.
The device can cause perforation (a hole in the digestive tract) during insertion, advancement, or removal. This risk is highlighted in updated instructions for use to ensure safer procedures.
Healthcare professionals using the device for endoscopic procedures and patients undergoing related surgeries are most at risk. The recall applies to all units sold with the specific model and lot numbers.
Check for the EXALT Model D Single-Use Duodenoscope (Box 1) with UPN M00542420. The device is intended for sterile, single-use procedures with the EXALT Controller.
Check the device for updated instructions for use that address perforation risks during procedures.
The device has known risks of perforation during procedures, so it is not safe without following updated instructions for use.
Look for the EXALT Model D Single-Use Duodenoscope (Box 1) with UPN M00542420.
Review the updated instructions for use to ensure safer procedures, but no immediate action is required beyond following the 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-1079-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1079-2022 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.
