EXALT Model D Duodenoscope Updated Instructions Address Known Perforation Risk
Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving an instructional update to address a known procedural risk. No adverse events or injuries are mentioned in the source text. The recall is precautionary in nature, with updated guidance provided to mitigate an inherent procedural risk.
Plain-English summary
The EXALT Model D Single-Use Duodenoscope is a sterile, single-use flexible video duodenoscope intended for examining the duodenum and performing various procedures within it, including endoscopy and endoscopic surgery. Boston Scientific Corporation is updating the Instructions for Use (IFU) for this device.
The updated IFU highlights the known risk of perforation and provides best clinical practices related to insertion, advancement, and removal of the device. The device has been distributed worldwide, including throughout the United States and in numerous international markets.
If you have received or are using EXALT Model D Duodenoscopes, review the updated instructions provided by Boston Scientific regarding proper handling and insertion techniques to minimize the risk of perforation during procedures.
The recalled product
- Product
- EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1,094
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots GTIN: 08714729995746
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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