Boston Scientific cardiac catheters recalled for polyurethane delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. Approximately 37,252 catheters in specific batches are affected 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: This is an FDA Class I recall, which carries a minimum severity score of 4 per the rubric. Although no injuries or deaths have been reported in the source text, the polyurethane delamination and material detachment in cardiac catheters can prevent proper guidewire advancement and potentially compromise critical diagnostic procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO AL1, 5-pack) used for cardiac angiographic procedures.
An increase in complaints has been received regarding inability to advance the guidewire through the catheter lumen. Investigation identified polyurethane layer delamination (layer separation) within the catheter inner lining, and in some instances, material detachment from the internal surface.
The recall affects approximately 37,252 catheters distributed in 35 specific batches worldwide, including the United States, U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
Patients and healthcare providers should not use the identified batch numbers and should contact Boston Scientific for information on replacement options or product return procedures.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 37,252
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 (20)
- UDI/DI 08714729187936
- Batch Numbers: 60438199
- 60453733
- 60472577
- 60486300
- 60500754
- 60513563
- 60438660
- 60459203
- 60473158
- 60491662
- 60507655
- 60529457
- 60440956
- 60465786
- 60477280
- 60495526
- 60507656
- 60533641
- 60445923
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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