The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0396-2024·Announced 2023-11-29

Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens

Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.

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 of a risk-of-harm medical device where fluid ingress compromises visualization during procedures. No illnesses or injuries reported, limiting the score to 3 per the rubric guideline that hazards without reported harm score at most 3.

Plain-English summary

Boston Scientific Corporation is recalling the EXALT Model D Single-Use Duodenoscope due to fluid ingress in the lens. The recall affects 586 devices distributed in the United States and 81 devices distributed internationally across countries including Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, and Switzerland.

The fluid ingress results in poor image quality during endoscopic procedures. This compromised visualization capability could impact clinical decision-making and procedural outcomes during diagnostic and therapeutic endoscopy.

Healthcare facilities and endoscopy centers using EXALT Model D Single-Use Duodenoscopes should verify whether they have devices from the affected lot/batch numbers. For UPN M00542420: lots 31137538, 31537335, 31228699, 31590604, 31257049, 31635405, 31257050, 31683854, 31258726, 31802917, 31329914, 31810037, 31398618, 31991955, 31438355, 32006891, 31473069, 32146684. For UPN M0054242CE0: lots 31199348, 31712358, 31574944. Affected devices should not be used. Contact Boston Scientific immediately for device replacement or return instructions.

The recalled product

Product
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Endoscope / Duodenoscope
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 (20)

  • UDI-DI (GTIN): 08714729983514
  • Outer box UPN# M00542420
  • Lot / Batch # 31137538
  • 31537335
  • 31228699
  • 31590604
  • 31257049
  • 31635405
  • 31257050
  • 31683854
  • 31258726
  • 31802917
  • 31329914
  • 31810037
  • 31398618
  • 31991955
  • 31438355
  • 32006891
  • 31473069
  • 32146684. UDI-DI (GTIN): 08714729995746

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

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