EXALT Model D Single-Use Duodenoscope Updated Guidance on Perforation Risk
Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.
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: FDA Class II recall with no reported illnesses or injuries. The recall action is a voluntary update to Instructions for Use to address a known procedural risk through improved clinical guidance, not a product defect correction.
Plain-English summary
Boston Scientific Corporation has issued updated Instructions for Use (IFU) for the EXALT Model D Single-Use Duodenoscope, a flexible video endoscope used to examine and treat the duodenum.
The updated instructions highlight a known risk of perforation (puncture) of the duodenal wall and provide best clinical practices for insertion, advancement, and removal of the device. Approximately 6,946 units have been distributed worldwide, including 6,916 units in the United States.
Healthcare providers using this device should review the updated instructions and ensure they are following proper techniques for handling and advancing the scope. The updated guidance is intended to help clinicians better manage the procedural risks associated with duodenoscope use.
The recalled product
- Product
- EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Endoscopy
- Hazard
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: 08714729993605
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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