Expo 5F cardiac catheters recalled for material delamination worldwide
Boston Scientific is recalling 2,990 Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the device lumen.
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. The manufacturing defect affects critical device function (guidewire advancement) in a cardiac interventional procedure. Per the severity rubric, FDA Class I recalls require a minimum score of 4 (Severe). No deaths or serious injuries have been reported.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter inner lining. The defect prevents the guidewire from advancing through the device lumen as intended.
The recall affects 2,990 catheters distributed worldwide, including the United States, U.S. Territories, EMEA, Canada, Latin America, and Asia Pacific regions. The defect has been identified in five specific batch numbers: 60438212, 60449780, 60491491, 60491959, and 60521828.
Healthcare providers and facilities should check their inventory for affected units by verifying the batch number and product reference number (H749085262202) against the recall information. Units from the affected batches should not be used. Institutions should contact Boston Scientific Corporation for replacement or instructions on disposition of affected catheters.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 2,990
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 (6)
- UDI/DI 08714729007531
- Batch Numbers: 60438212
- 60449780
- 60491491
- 60491959
- 60521828
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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