EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk
Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe 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 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: FDA Class II recall addressing a known perforation risk with no reported injuries or hospitalizations. The remedy is updated instructions providing best clinical practices, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The EXALT Model D Single-Use Duodenoscope is a sterile, single-use flexible video duodenoscope manufactured by Boston Scientific Corporation. It is intended for use with the EXALT Controller to examine the duodenum and perform various procedures within the duodenum, including endoscopy and endoscopic surgery.
Boston Scientific has updated the device's Instructions for Use to address a known risk of perforation. The updated instructions highlight clinical best practices for the insertion, advancement, and removal of the device to help reduce this risk.
Approximately 538 units of this device were distributed to locations outside the United States. Healthcare providers using this device should review the updated Instructions for Use and implement the recommended best practices for device insertion, advancement, and removal to minimize the perforation risk.
The recalled product
- Product
- EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 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
- 538
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: 08714729995753
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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