Recall Z-0243-2016— Medtronic Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2015-10-23, terminated 2017-07-31. It names 4 FDA 510(k) clearances: K083919, K052791, K050073 and 1 more. Product: 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 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD030080002 AMD035150002 AMD040150152 AMD354210152 AMD030080152 AMD035150152 AMD225210002 AMD030120002 AMD040040152 AMD225210152 AMD030120152 AMD040080002 AMD253210002 AMD030150002 AMD040080152 AMD253210152 Cardiovascular: Intended for use in Angioplasty. 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..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-23
- Terminated
- 2017-07-31
- Firm location
- Santa Rosa, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K083919 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K052791 — MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K050073 — MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K042624 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD030080002 AMD035150002 AMD040150152 AMD354210152 AMD030080152 AMD035150152 AMD225210002 AMD030120002 AMD040040152 AMD225210152 AMD030120152 AMD040080002 AMD253210002 AMD030150002 AMD040080152 AMD253210152 Cardiovascular: Intended for use in Angioplasty
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.