Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
This recall is currently active, issued May 10, 2024. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- March 21, 2024
- Posted
- May 10, 2024
- Recall Number
- Z-1638-2024
- Quantity
- 16797 catheters
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Distribution
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Lot / Code Info
UDI/DI 08714729187684, Batch Numbers: 60425778, 60427745, 60438674, 60456279, 60465785, 60476456, 60427256, 60430877, 60440972, 60465783, 60472599, 60479447, 60427594, 60430933, 60449235, 60465784, 60474047, 60479448, 60474048, 60522588
Root Cause
Under Investigation by firm
Action Taken
Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees.