Device product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
Z-1678-2024
Product summary
- Event
- Event 94240
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 615 catheters
- Official record key
device-enforcement:Z-1678-2024
Official wording
Reason: 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.
Code information: UDI/DI 08714729812203, Batch Numbers: 60447147, 60467099, 60492626
Distribution pattern: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Derived failure modes
-
Unknown
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.