Expo 5F Selective Angiographic Catheters recalled for material delamination and device malfunction
Boston Scientific is recalling 1,322 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement. The defect could compromise cardiac catheterization procedures.
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 recall classification requires a minimum severity score of 4. This cardiac catheter malfunction due to material delamination presents significant risk of procedure failure and potential patient harm, consistent with Class I designation.
Plain-English summary
Boston Scientific Corporation is recalling 1,322 Expo 5F Selective Angiographic Catheters (Model 5F EXPO WRP, Reference H74908526511) worldwide, including distribution to the United States, U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
The catheters are affected by polyurethane layer delamination and material detachment in the inner lining. These defects result in complaints of inability to advance the guidewire through the catheter lumen, which could compromise the cardiac catheterization procedure.
The affected batch numbers are 60442598, 60442599, 60448185, 60459199, 60488391, 60490138, 60451431, 60467097, 60490137, and 60490168.
Healthcare providers and facilities are advised to identify and immediately stop using affected catheters and contact Boston Scientific Corporation regarding replacement or return of the product.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,322
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 08714729249498
- Batch Numbers: 60442598
- 60442599
- 60448185
- 60459199
- 60488391
- 60490138
- 60451431
- 60467097
- 60490137
- 60490168
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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