Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) Th
FDA device recall Z-1758-2015 · posted 2015-06-11 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Potential device damage on the strain relief near the hub area, which may result in blood leakage.
- Action taken
- Urgent Medical Device Safety Notice letters were sent via Fed-Ex by May 05, 2015. As part of the customer instructions in the safety notice, customers were requested to review the notice to understand the potential hazard, complete and return the acknowledgement form, and forward copies of the Safety Notice to any organization where the potentially affected devices have been transferred. The device will only be distributed to customers who have returned the acknowledgement form. Questions should be directed to Edwards Customer Service at 800-424-3278.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 3,360 units.
- Distribution
- Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Miss
- Date initiated
- 2015-05-05
- Date posted
- 2015-06-11
- Date terminated
- 2017-12-12
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K132175) | Edwards Lifesciences, LLC | 2013-09-13 |