Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific recalled Expo 5F cardiac catheters due to polyurethane delamination preventing guidewire advancement. The defect may cause device failure during medical procedures.
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 a Class I FDA medical device recall. The severity rubric requires a minimum score of 4 (Severe) for Class I recalls. No illnesses or injuries are reported; however, the Class I designation reflects a serious functional defect in a cardiac catheter that could prevent device use during critical medical procedures.
Plain-English summary
Boston Scientific Corporation has recalled approximately 1,170 Expo 5F Selective Angiographic Catheters (Model 5F EXPO IMC) due to a manufacturing defect in certain batches. The polyurethane layer of these cardiac catheters is delaminating and material is detaching in some units, which prevents the guidewire from advancing through the catheter lumen.
The affected devices were distributed worldwide, including the United States, U.S. territories, EMEA, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are 60448987, 60467091, 60476275, 60486323, and 60535894. The device UDI/DI is 08714729249214.
The primary concern is that physicians attempting to use an affected catheter during an angiographic procedure may be unable to advance the guidewire through the device. Healthcare facilities and physicians should verify batch numbers of devices in their inventory and ensure affected units are not used until further instruction from Boston Scientific.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- delamination
- material-detachment
- device-malfunction
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 (6)
- UDI/DI 08714729249214
- Batch Numbers: 60448987
- 60467091
- 60476275
- 60486323
- 60535894
Distribution
Distribution scope not specified by the agency.
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