Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwa
FDA device recall Z-0644-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
- Action taken
- All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 1267 units
- Distribution
- Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA a
- Date initiated
- 2008-11-26
- Date posted
- 2009-01-05
- Date terminated
- 2011-08-10
- 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 (K964161) | Heartport, Inc. | 1997-04-04 |