Recall Z-0243-2016 ยท DQY Catheter, Percutaneous
Medtronic Vascular, Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; OUS: AMD025150152 AMD030
| Date | Nov 6, 2015 (initiated Oct 23, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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. |
| Quantity | 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 Georgia Germany Hong Kong Hungary India Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L., Jan 10, 2005 |
| K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L., Feb 11, 2005 |
| K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L., Nov 4, 2005 |
| K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L., Mar 13, 2009 |