Expo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
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 applies, establishing a minimum severity of 4 per the rubric. The polyurethane delamination and material detachment prevent proper device function during critical cardiac catheterization procedures.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters used in cardiac catheterization procedures. The affected batches are: 60451436, 60470651, 60490172, and 60495478 (Reference H749085263011, UDI/DI 08714729521518). Approximately 847 catheters in these batches are affected.
The polyurethane layer in the catheter lumen is delaminating and in some instances detaching from the inner lining. This structural defect prevents guidewires from advancing properly through the catheter during medical procedures.
These catheters were distributed worldwide to healthcare facilities in the United States, U.S. Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 847
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 (5)
- UDI/DI 08714729521518
- Batch Numbers: 60451436
- 60470651
- 60490172
- 60495478
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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