Boston Scientific recalls EXALT Model D Single-Use Duodenoscopes due to perforation risk during use. Affected units have specific GTIN and were sold with EXALT Controller. Consumers should contact for details.
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 exists even with proper use, so affected users should stop using the device and contact the company for instructions.
The duodenoscope can cause perforation (a hole in the intestine) during insertion, advancement, or removal if not used correctly. This risk is highlighted in the updated instructions for use, which provide best practices to reduce the chance of injury.
Healthcare professionals who use the EXALT Model D duodenoscope for medical procedures are most at risk. Patients who have been treated with this device may also be affected if they experience complications.
Check for the GTIN: 08714729995746 on the product box. The device was sold with the EXALT Controller for duodenal procedures and is intended for single-use medical procedures.
Reach out to Boston Scientific for specific instructions on how to handle the recalled device.
The device has a known risk of perforation during use, so it should not be used without following the updated instructions for use.
Check the GTIN: 08714729995746 on the product box. The device was sold with the EXALT Controller for duodenal procedures.
Contact Boston Scientific for specific instructions on how to handle the recalled device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1081-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1081-2022 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.
