Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP04004
FDA device recall Z-0243-2016 · posted 2015-11-06 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular, Inc.
- Reason for recall
- Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
- Action taken
- Beginning October 23, 2015, Medtronic will send the customer letter and confirmation form to all identified US customers via 2-day UPS mail delivery. Internationally, communications will be sent per locally approved methods.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 1652 units in US; 4243 units OUS.
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Geor
- Date initiated
- 2015-10-23
- Date posted
- 2015-11-06
- Date terminated
- 2017-07-31
- Location
- Santa Rosa, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K083919) | Invatec Innovative Technologies, S.R.L. | 2009-03-13 |
| MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K052791) | Invatec Innovative Technologies, S.R.L. | 2005-11-04 |
| MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K050073) | Invatec Innovative Technologies, S.R.L. | 2005-02-11 |
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K042624) | Invatec Innovative Technologies, S.R.L. | 2005-01-10 |