FDA Recalls Boston Scientific Expo 5F Cardiac Catheters Due to Delamination
Boston Scientific is recalling 8,575 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement. The FDA Class I recall affects devices distributed worldwide.
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: FDA Class I classification mandates a minimum severity score of 4 per the rubric. The polyurethane delamination and material detachment render the device unable to perform its critical cardiac function, meeting the criteria for Severe.
Plain-English summary
Boston Scientific Corporation is recalling 8,575 Expo 5F Selective Angiographic Catheters (Model 5F EXPO WRP, Reference H74908526512) due to manufacturing defects in the catheter construction. The catheters, which are cardiac angiography devices, are affected by polyurethane layer delamination and material detachment in the inner lining that prevents the guidewire from advancing through the catheter lumen.
This Class I recall affects 21 specific batch numbers that were distributed worldwide, including the US, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. The defect was identified through an increase in complaints regarding inability to advance the guidewire through the device.
Healthcare providers and patients should stop using affected catheters. Affected units can be identified by the UDI/DI 08714729249504 and the specific batch numbers listed in the recall notice.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- delamination
- material-integrity-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 (20)
- UDI/DI 08714729249504
- Batch Numbers: 60442603
- 60448206
- 60463966
- 60481407
- 60491911
- 60492607
- 60443053
- 60457140
- 60467045
- 60485945
- 60492554
- 60492608
- 60443054
- 60457142
- 60467046
- 60488392
- 60492605
- 60448186
- 60463965
Distribution
Distribution scope not specified by the agency.
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