Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac cat due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026