Cardiac catheters recalled for guidewire advancement failure due to material delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures. The recall affects 4,715 catheters 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: This is an FDA Class I recall, which the severity rubric mandates a minimum score of 4. The product malfunction (polyurethane delamination preventing guidewire advancement) occurs in a critical cardiac procedure context. No deaths or hospitalizations are explicitly reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling specific batches of Expo 5F Selective Angiographic Catheters, model 5F EXPO FL4.5, used during cardiac angiographic procedures. The recall addresses complaints of inability to advance guidewires through the device lumen in certain batches. Investigation identified polyurethane layer delamination and material detachment in the catheters' inner lining as the cause.
The 4,715 affected catheters were distributed worldwide to the United States, US territories, EMEA, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are: 60443928, 60457123, 60464496, 60473188, 60504888, 60522597, 60477305, 60517337, and 60533589, identified by UDI/DI 08714729187837.
This is an FDA Class I recall initiated by Boston Scientific Corporation. The device malfunction poses a risk during cardiac interventions when guidewire advancement is required for proper catheter positioning and use.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,715
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 (10)
- UDI/DI 08714729187837
- Batch Numbers: 60443928
- 60457123
- 60464496
- 60473188
- 60504888
- 60522597
- 60477305
- 60517337
- 60533589
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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Same hazard · material delamination
See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
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FDA (Devices) · 2024-05-22
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FDA (Devices) · 2024-05-22
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FDA (Devices) · 2024-05-22
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FDA (Devices) · 2024-05-22
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