Z-1678-2024 Class I Ongoing
FDA device recall Z-1678-2024 was initiated by Boston Scientific Corporation on March 21, 2024 and is designated Class I. 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 ins… The recall status is ongoing. Affected quantity: 615 catheters.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- March 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 615 catheters
Product Description
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
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 Pattern
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Code Information
UDI/DI 08714729812203, Batch Numbers: 60447147, 60467099, 60492626