FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk
Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a known risk of perforation. No illnesses or injuries are reported in the source text. The recall is being addressed through updated instructional guidance on procedural best practices rather than device removal, indicating a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Boston Scientific's EXALT Model D Single-Use Duodenoscope, a flexible video device used to examine the duodenum and perform endoscopic procedures, is the subject of updated safety instructions from the FDA. A total of 1,486 units have been distributed (1,441 in the US and 45 internationally) and are in use across the United States and numerous other countries.
The FDA has required updated Instructions for Use that highlight a known risk of perforation associated with the device. The updated instructions provide best clinical practices for proper insertion, advancement, and removal to help healthcare providers minimize this risk during procedures.
Healthcare facilities and medical professionals using the EXALT Model D should obtain and review the updated Instructions for Use immediately. All existing units distributed under GTIN 08714729983514 should comply with the new safety guidance.
The recalled product
- Product
- EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 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
- 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: 08714729983514
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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