EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Steril
FDA device recall Z-0084-2010 · posted 2009-11-06 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Balloon catheters were spontaneously rupturing during use.
- Action taken
- Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 2,737 total
- Distribution
- Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
- Date initiated
- 2009-09-24
- Date posted
- 2009-11-06
- Date terminated
- 2012-04-25
- Location
- Midvale, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTPORT ENDOAORTIC CLAMP (K964161) | Heartport, Inc. | 1997-04-04 |
| HEARTPORT ENDOAORTIC CLAMP (K962510) | Heartport, Inc. | 1996-09-11 |
| HEARTPORT ENDOAORTIC CLAMP (K955132) | Heartport, Inc. | 1996-06-07 |