Angiographic Catheters Recalled for Polyurethane Delamination and Malfunction
Boston Scientific recalls Expo 5F angiographic catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The recall affects 3,127 units in specific batches 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. The polyurethane delamination and material detachment cause functional failure in critical cardiac catheters, preventing guidewire advancement.
Plain-English summary
Boston Scientific Corporation is recalling the Expo 5F Selective Angiographic Catheters (Model 5F EXPO RCB, reference H749085261902) due to a defect in the device's polyurethane layer. The catheters are failing in certain batches because of polyurethane delamination and material detachment in the inner lining, which prevents guidewires from advancing properly through the device.
The recall affects 3,127 catheters across eight specific batches distributed worldwide, including the United States, U.S. Territories, Europe, Middle East, Africa, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are 60447160, 60463413, 60472609, 60481602, 60493975, 60517338, 60511235, and 60533588.
Healthcare facilities and clinicians using these catheters should immediately discontinue use of affected batches and contact Boston Scientific for return or replacement instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 3,127
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 (9)
- UDI/DI 08714729168928
- Batch Numbers: 60447160
- 60463413
- 60472609
- 60481602
- 60493975
- 60517338
- 60511235
- 60533588
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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