Cardiac Catheters Recalled Due to Delamination and Device Malfunction
Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.
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: This is classified as FDA Class I by the FDA, which establishes a minimum severity score of 4 per the rubric. The defect involves material delamination and detachment in the device's inner lining that prevents guidewire advancement—a critical functional failure of a cardiac catheter.
Plain-English summary
Boston Scientific Corporation is recalling 8,725 Expo 5F Selective Angiographic Catheters (Model 5F EXPO FL3) worldwide due to a manufacturing defect affecting device functionality.
The catheters are subject to polyurethane layer delamination, and in some instances, material detachment in the inner lining. This defect prevents the guidewire from advancing through the device's lumen, which is essential for proper catheter positioning during angiographic procedures.
The recalled catheters are identified by UDI/DI 08714729376675. Affected batch numbers are: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, and 60517330. The affected units were distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8,725
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 (12)
- UDI/DI 08714729376675
- Batch Numbers: 60433909
- 60459200
- 60467047
- 60486322
- 60504866
- 60533642
- 60447140
- 60463976
- 60474043
- 60504859
- 60517330
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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