Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US:… — Class II medical device recall Z-0243-2016
Terminated recall by Medtronic Vascular, Inc., reported 2015-11-18, distributed nationwide. Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential
| Recall number | Z-0243-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2015-10-23 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2017-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FR, GB, HK, HU, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MX, NL, NO, OM, PA, PE, PH, PK, PL, PT, SA, SE, SG, SI, SK, TH, TR, TT, TW, UY, ZA |
| Reason classes | packaging |
| Lot numbers | 209406892, 209406894, 209425763, 209425766, 209425767, 209425768, 209425769, 209425770, 209425771, 209425773, 209425778, 209425802, 209425805, 209425806, 209425807, 209436574, 209436575, 209436576, 209436577, 209436578, 209436579, 209436620, 209436621, 209436622, 209436623, 209436624, 209436625, 209436626, 209436627, 209436628, 209470464, 209470465, 209470466, 209470467, 209470468, 209470469, 209470470, 209470471, 209470472, 209470473 and 440 more |
| Model numbers | AMP015020152, AMP020040152, AMP020080152, AMP020120152, AMP020150152, AMP025040152, AMP025080002, AMP025080152, AMP025120152, AMP025150152, AMP030040002, AMP030040152, AMP030080152, AMP030120152, AMP030150152, AMP035120152, AMP040040152, AMP040080152, AMP040120152, AMP040150152, AMP225210152, AMP253210152, AMP335210152, AMP354210152 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0243-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.