Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this as a Class I recall. Per the severity rubric, FDA Class I classification constitutes a Critical-level recall regardless of whether adverse events have been reported.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO MULTIPACK (SGL), Reference Number H749085263001. A total of 363 units are affected, distributed worldwide with batch numbers 60443927 and 60495422.
The catheters have delamination of the polyurethane layer and material detachment in the catheter's inner lining. These defects prevent the guidewire from advancing properly through the catheter's lumen, impairing device functionality during cardiac angiography procedures.
The affected catheters have been distributed to healthcare facilities worldwide, including in the US, US Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions. The FDA has classified this recall as Class I.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 363
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 (3)
- UDI/DI 08714729521501
- Batch Numbers: 60443927
- 60495422
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 48 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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