Cardiac catheters recalled due to polyurethane layer delamination defects
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.
What this means for you
Illness, injury, or structural failure has been reported. 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 requires a minimum severity score of 4. The device is a critical cardiac catheter used in invasive coronary procedures. The defect (polyurethane delamination and material detachment) affects core device functionality and poses risk of harm, though no injuries have been reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO FR4 MOD, due to manufacturing defects in the polyurethane layer. These are cardiac catheters used in angiographic procedures.
The recalled devices exhibit an increase in complaints involving inability to advance the guidewire through the catheter lumen. The defect involves delamination of the polyurethane layer and, in some cases, detachment of material from the inner lining of the catheter.
The recall affects 385 catheters with batch numbers 60448979, 60500188, and 60535893. These catheters have been distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- delamination
- material-detachment
- functional-failure
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 (4)
- UDI/DI 08714729248705
- Batch Numbers: 60448979
- 60500188
- 60535893
Distribution
Distribution scope not specified by the agency.
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