Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter
FDA device recall Z-1664-2024 · posted 2024-05-10 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DQO
- Quantity affected
- 10 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Date initiated
- 2024-03-21
- Date posted
- 2024-05-10
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Impulse Angiographic Catheter, Expo Angiographic Catheter (K152605) | Boston Scientific Corporation | 2015-10-29 |