EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edw
FDA device recall Z-0085-2010 · posted 2009-11-06 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Spontaneous balloon rupture during use of the product.
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) | Heartport, Inc. | 1997-12-16 |
| 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 |