ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W03004
FDA device recall Z-0789-2011 · posted 2010-12-23 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in material separation and potential embolization.
- Action taken
- A Medical Device Recall letter addressed to Risk Managers, dated 11/10/2010, was sent to hospitals beginning 11/12/2010. The letter identified the affected devices, described the issue and requested that affected devices be located and removed from use. ev3 sales representatives will contact customers to arrange return of all unused devices. A credit or replacement will be provided for any unused devices. Questions regarding this issue may be directed towards Customer Service at 800-716-6700.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 4,962 (3,858 US; 1,104 OUS)
- Distribution
- Worldwide Distribution -- USA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MALTA, NETHERLA
- Date initiated
- 2010-11-12
- Date posted
- 2010-12-23
- Date terminated
- 2011-05-17
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 (K090849) | Ev3, Inc. | 2009-05-01 |
| NANOCORSS .014 OTW PTA DILATATION CATHETER (K082854) | Ev3, Inc. | 2008-12-04 |