CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Amphirion Deep OTW PTA Balloon Catheter recalled by Medtronic Vascular
Medtronic Vascular is recalling Amphirion Deep OTW PTA Balloon Catheter, distributed nationwide in the US. The recall was initiated on 23 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0243-2016
- FDA event ID
- 72502
- Recalling firm
- Medtronic Vascular, Santa Rosa, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2015
- FDA classified
- 6 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 23 Oct 2015 | Recall initiated by company | |
| 6 Nov 2015 | Classified by FDA | +14 days |
| 18 Nov 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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 Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Oman Pakistan Panama Peru Philippines Poland Portugal Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syria Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom and Uruguay. .
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model number/lot numbers: AMD015020002: 209633629; 209882401; 209981044; AMD015020151; 209436628; AMD015020152; 209821677; 209900858; 210046728 AMD020040002; 209425805; 209601495; 209760077; 209821680; AMD020040152; 209406894;209425802;209471311; 209532785; 209551995;209601496; 209664056; 209759618; 209759619; 209855564; AMD020080002: 209821676; 209855251; 209901400; 210005917; 210046729; AMD020080152: 209436625; 209470469; 209470470; 209532768; 209551997 209760064; 209760065; 209855561; 209900855; AMD020120002; 209722681; 209760093 AMD020120152: 209470465; 209470468; 209532777; 209551996; 209601499 209722674; 209760062; 209760063; 209821673; 209855560; 209900846; 209911605; AMD020150002: 209532784; 209601620; 209664054; 209722667; 209760060; 209981040; 210005913; AMD020150152: 209425766; 209436575; 209509786; 209532790; 209633607; 209664057; 209722685; 209760082; 209855565; 209882402; 209900852; 209911606; 210046730; AMD025040152: 209471307; 209722670; 209821666; 209882403; 209900853; 210046726; AMD025080152; 209406892; 209425768; 209471303; 209509782; 209509783; 209532791; 209601621; 209633611; 209664058; 209760080; 209821679; 209855566; 209882404; 209911600; AMD025120002: 209532776; 209551998; 209760088; AMD025120152: 209470467;209532762; 209664055; 209760069; 209794025; 209882405; 209900851; 209917255; AMD025150002: 209425767; 209553428; 209633606; 209722660; 209760091; 209911603; AMD025150152: 209425771; 209436620; 209470477; 209509781; 209553429; 209633608; 209722663; 209760076; 209900857; 209911517; 210005909; 210046732; AMD030040002: 209821681; AMD030040152: 209471306: 209509785: 209553420; 209601625; 209760061; AMD030080002: 209436579; 209855252; AMD030080152: 209470478; 209532782; 209553421; 209722662; 209759614: 209759615; 209917248; 209981041; 210005915; AMD030120002: 209425806; 209509784; 209601627;209760094 AMD030120152: 209601628; 209722477; 209760068; 209917242; 209981042. AMD030150002: 209530579; 209553422; 209759610; 209759611; 209821674 AMD030150152: 209507756; 209507757; 209633602; 209722678; 209759612; 209759613; 209855257; AMD035040152: 209634197; 209980257; AMD035120002: 209436577; 209553423; AMD035150002: 209633627; AMD035150152: 209436574; 209633625; 209635221; 209980247; 210046727; AMD040040152: 209425770; 209470473; 209532789; 209553424; 209601629; 209855563; 209900854; AMD040080002: 209436627; AMD040080152: 209601630; 209634198; 209882406; 209980249; 210005903; 210046733; AMD040120002: 209425807; AMD040120152: 209532778; 209601631; 209635220; 209855562; 209911519; 210046725; AMD040150002: 209470464; AMD040150152: 209425763; 209471313; 209532761; 209553425; 209823991; AMD225210002: 209601633; 209722478; 209760078; 209917256; 209980250; 210005904; AMD225210152: 209436626; 209471308; 209532760; 209664048; 209722661; 209760071; 209760072; 209821675; 209855568; 209855569; 209917244; 209917245; 209917246; 209980252; 209980253; 209980254; AMD253210002: 209425769; 209436621; 209532788; 209553426; 209633600; 209722680; 209760070; 209968089; 209981043; 210005912; AMD253210152: 209471301; 209507758; 209509780; 209532771; 209553427; 209633604; 209664051; 209760066; 209760067; 209794020; 209821678; 209882407; 209882408; 209968083; 209968088; 209968091; 209980255; 209980256; 210005914; AMD335210002: 209633603; 209664050; 209760087; 209855567; 209882409; 209968085; AMD335210152; 209470466; 209507754; 209507755; 209633601; 209664049 209760079; 209793539; 209821554; 209855259; 209882410; 209968084; 209968092; 209980259; AMD354210002: 209470475; AMD354210152: 209470474; 209532787; 209633610; 209722475; 209980248; 210005905; AMP015020152: 209471310: 209532780; 209633623; 209722671; 209760084; 209794023; 209900845; AMP020040152: 209436622; 209532772; 209633618; 209722666; 209760074; 209821557; 209900859; AMP020080152: 209425773; 209471314; 209532786; 209633621; 209722677 209821558; 209900850; 209917250; 210006063; AMP020120152: 209470476; 209532765; 209722683; 209821664; 209855254; AMP020150152: 209436576; 209471312; 209532781; 209633620; 209722673; 209760090; 209821672; 209917249; AMP025040152: 209633628; 209760083; 209821667; 209917253 ; AMP025080002: 209633624; AMP025080152: 209471304; 209532774; 209633630; 209821668; 209917247; AMP025120152: 209470472; 209532766; 209633612; 209722679; 209794021; 209917252; 209980258; 210005907; AMP025150152: 209471302; 209722474; 209794022; 210046785; AMP030040002: 209722672; AMP030040152: 209436578; 209532779; 209633613; 209722668; 209760095; 209821665; 209900856; AMP030080152: 209532769; 209633619; 209722664; 209760089; 209821671; 209917254; 210005919; AMP030120152 : 209471309; 209532773; 209633617; 209722665; 209760086; 209821670; 209882411; AMP030150152: 209436623; 209532764; 209633615; 209722479; 209760085; 209794024; AMP035120152: 209470479; 209633616; 209722676: AMP040040152; 209470471; 209532767; 209633622; 209760081; 209821555; 209882412; 209900844; 209917251; 210006061; AMP040080152: 209821559; 210046724; AMP040120152: 209471315; 209855253; 209882413; 210005918; AMP040150152: 209532775; 209722682; 209821669; 209900847; 210005911; AMP225210152: 209436624; 209471305; 209532763; 209759616; 209759617; 209821660; 209821661; 209821662; 209821663; 209855255; 209855256; 209968082; 209968087; 209968090; 209980251; 210005906; AMP253210152; 209425778; 209471300; 209532770; 209633614; 209664053; 209722675; 209760073; 209821556; 209900849; 210006060; AMP335210152: 209633605; 209722669; 209760096; 209917243; AMP354210152: 209532783; 209760092; 209900848.
Where was it sold?
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 Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Oman Pakistan Panama Peru Philippines Poland Portugal Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syria Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom and Uruguay. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Vascular
All 227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled | Medtronic Vascular | Sterility | Nationwide |
| Device | CLASS II | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled | Medtronic Vascular | Sterility | Nationwide |
| Device | CLASS II | Endurant IIs Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
| Device | CLASS II | Endurant Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
| Device | CLASS II | Endurant II Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |