Boston Scientific recalls EXALT Model D Single-Use Duodenoscope (Box 2) 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 Duodenoscope (Box 2) because it can cause perforation during medical procedures. This risk is serious and requires immediate attention from healthcare providers using the device.
The device can cause perforation (a hole in the digestive tract) during insertion, advancement, or removal. This risk is heightened by improper use or inadequate clinical practices as highlighted in the updated instructions.
Healthcare providers who use the EXALT Model D Single-Use Duodenoscope for medical procedures are most at risk. Patients undergoing procedures with this device may also be affected.
Check for the EXALT Model D Single-Use Duodenoscope (Box 2) with GTIN 08714729995753. The device was sold with the EXALT Controller for duodenal procedures.
Immediately stop using the EXALT Model D Single-Use Duodenoscope if you have it for medical procedures.
No, the device has a known risk of perforation during use, so it should not be used until the recall is addressed.
Check for the EXALT Model D Single-Use Duodenoscope (Box 2) with GTIN 08714729995753 that was sold with the EXALT Controller.
Contact Boston Scientific directly for instructions on how to return or dispose of the device safely.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1082-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1082-2022 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.
