Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect prevents guidewire advancement through 1065 affected devices 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4 (Severe). The defect—polyurethane delamination preventing guidewire advancement—creates risk of procedure failure or patient injury during cardiac interventions.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO IM 125CM, due to polyurethane layer delamination and material detachment in the catheter inner lining. The defect results in an inability to advance the guidewire through the device lumen, preventing proper function during cardiac angiographic procedures.
The recall involves 1065 catheters from batches 60444872, 60451459, 60451968, and 60511220. These devices have been distributed worldwide, including to the United States, U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,065
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 (5)
- UDI/DI 08714729007593
- Batch Numbers: 60444872
- 60451459
- 60451968
- 60511220
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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See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
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