Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination Risk
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac 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: This is an FDA Class I recall of a critical cardiac catheter. Although no illnesses or injuries have been reported, the polyurethane delamination defect directly impairs the device's intended function, preventing guidewire advancement during cardiac procedures. FDA Class I recalls, by definition, indicate situations where serious adverse health consequences or death are reasonably probable.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO MULTIPACK 145, Reference H749085265002) due to a defect in the polyurethane layer within the catheter's inner lining. The defect involves delamination and, in some instances, material detachment.
The polyurethane delamination prevents the guidewire from advancing through the catheter's lumen. This obstruction compromises the catheter's ability to function as intended during cardiac angiographic procedures.
The recall affects approximately 105 catheters with Batch Number 60480059 (UDI/DI 08714729249382). Affected units were distributed worldwide, including to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 105
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 (2)
- UDI/DI 08714729249382
- Batch Numbers: 60480059
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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