Expo 5F Cardiac Catheters recalled due to delamination defect
Boston Scientific is recalling 8,715 Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane delamination that prevents guidewire advancement. The affected units were 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 classification requires a minimum severity score of 4. The source does not report injuries or deaths, but the potential for device malfunction due to delamination and material detachment—which prevents proper guidewire advancement—poses significant clinical risk in a critical cardiac procedure.
Plain-English summary
Boston Scientific Corporation is recalling 8,715 Expo 5F Selective Angiographic Catheters (Model 5F EXPO AL2) due to a manufacturing defect affecting certain batches. The affected catheters carry UDI/DI 08714729187943 and include the following batch numbers: 60434245, 60454961, 60477302, 60510080, 60536207, 60447166, 60474029, 60483669, 60533638, and 60540481.
The defect involves polyurethane layer delamination and material detachment in the inner lining of the catheters. This can prevent the guidewire from advancing through the device lumen, potentially impairing its intended clinical function.
The affected catheters were distributed worldwide, including to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia-Pacific countries and regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8,715
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 (11)
- UDI/DI 08714729187943
- Batch Numbers: 60434245
- 60454961
- 60477302
- 60510080
- 60536207
- 60447166
- 60474029
- 60483669
- 60533638
- 60540481
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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