Reported Nov 18, 2015 · Terminated
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152…
Medtronic Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular, Inc. · 3576 Unocal Pl · Santa Rosa, CA · 95403-1774
Is this the product you have?
- Amphirion Deep OTW PTA Balloon CatheterModel
- numbersUS:
AMP015020152AMP020150152AMP025120152AMP030080152AMP040040152AMP225210152AMP020040152AMP025040152AMP025150152AMP030120152AMP040080152AMP253210152AMP020080152AMP025080002AMP030040002AMP030150152AMP040120152AMP335210152AMP020120152AMP025080152AMP030040152AMP035120152AMP040150152AMP354210152
- OUS
AMD025150152AMD030150152AMD040120002AMD335210002AMD030040002AMD035040152AMD040120152AMD335210152AMD030040152AMD035120002AMD040150002AMD354210002AMD030080002AMD035150002AMD040150152AMD354210152AMD030080152AMD035150152AMD225210002AMD030120002AMD040040152AMD225210152AMD030120152AMD040080002AMD253210002AMD030150002AMD040080152
- AMD253210152 CardiovascularIntended for use in Angioplasty
- Lot codes and dates
- Model number/lot numbers
AMD015020002: 209633629209882401209981044AMD015020151209436628AMD015020152209821677209900858210046728 AMD020040002209425805209601495209760077209821680AMD020040152209406894209425802209471311209532785209551995209601496209664056209759618209759619209855564
- AMD020080002
209821676209855251209901400210005917210046729
- AMD020080152
209436625209470469209470470209532768209551997 209760064209760065209855561209900855AMD020120002209722681209760093
- AMD020120152
209470465209470468209532777209551996209601499 209722674209760062209760063209821673209855560209900846209911605
- AMD020150002
209532784209601620209664054209722667209760060209981040210005913
- AMD020150152
209425766209436575209509786209532790209633607209664057209722685209760082209855565209882402209900852209911606210046730
- AMD025040152
209471307209722670209821666209882403209900853210046726AMD025080152209406892209425768209471303209509782209509783209532791209601621209633611209664058209760080209821679209855566209882404209911600
- AMD025120002
209532776209551998209760088
- AMD025120152
209470467209532762209664055209760069209794025209882405209900851209917255
- AMD025150002
209425767209553428209633606209722660209760091209911603
- AMD025150152
209425771209436620209470477209509781209553429209633608209722663209760076209900857209911517210005909210046732
- AMD030040002209821681
- AMD030040152
209471306: 209509785: 209553420209601625209760061
- AMD030080002
209436579209855252
- AMD030080152
209470478209532782209553421209722662209759614: 209759615209917248209981041210005915
- AMD030120002
209425806209509784209601627209760094
- AMD030120152
209601628209722477209760068209917242209981042
- AMD030150002
209530579209553422209759610209759611209821674
- AMD030150152
209507756209507757209633602209722678209759612209759613209855257
- AMD035040152
209634197209980257
- AMD035120002
209436577209553423
- AMD035150002209633627
- AMD035150152
209436574209633625209635221209980247210046727
- AMD040040152
209425770209470473209532789209553424209601629209855563209900854
- AMD040080002209436627
- AMD040080152
209601630209634198209882406209980249210005903210046733
- AMD040120002209425807
- AMD040120152
209532778209601631209635220209855562209911519210046725
- AMD040150002209470464
- AMD040150152
209425763209471313209532761209553425209823991
- AMD225210002
209601633209722478209760078209917256209980250210005904
- AMD225210152
209436626209471308209532760209664048209722661209760071209760072209821675209855568209855569209917244209917245209917246209980252209980253209980254
- AMD253210002
209425769209436621209532788209553426209633600209722680209760070209968089209981043210005912
- AMD253210152
209471301209507758209509780209532771209553427209633604209664051209760066209760067209794020209821678209882407209882408209968083209968088209968091209980255209980256210005914
- AMD335210002
209633603209664050209760087209855567209882409209968085AMD335210152209470466209507754209507755209633601209664049 209760079209793539209821554209855259209882410209968084209968092209980259
- AMD354210002209470475
- AMD354210152
209470474209532787209633610209722475209980248210005905
- AMP015020152
209471310: 209532780209633623209722671209760084209794023209900845
- AMP020040152
209436622209532772209633618209722666209760074209821557209900859
- AMP020080152
209425773209471314209532786209633621209722677 209821558209900850209917250210006063
- AMP020120152
209470476209532765209722683209821664209855254
- AMP020150152
209436576209471312209532781209633620209722673209760090209821672209917249
- AMP025040152
209633628209760083209821667209917253
- AMP025080002209633624
- AMP025080152
209471304209532774209633630209821668209917247
- AMP025120152
209470472209532766209633612209722679209794021209917252209980258210005907
- AMP025150152
209471302209722474209794022210046785
- AMP030040002209722672
- AMP030040152
209436578209532779209633613209722668209760095209821665209900856
- AMP030080152
209532769209633619209722664209760089209821671209917254210005919
- AMP030120152
209471309209532773209633617209722665209760086209821670209882411
- AMP030150152
209436623209532764209633615209722479209760085209794024
- AMP035120152
209470479209633616209722676: AMP040040152209470471209532767209633622209760081209821555209882412209900844209917251210006061
- AMP040080152
209821559210046724
- AMP040120152
209471315209855253209882413210005918
- AMP040150152
209532775209722682209821669209900847210005911
- AMP225210152
209436624209471305209532763209759616209759617209821660209821661209821662209821663209855255209855256209968082209968087209968090209980251210005906AMP253210152209425778209471300209532770209633614209664053209722675209760073209821556209900849210006060
- AMP335210152
209633605209722669209760096209917243
- AMP354210152
209532783209760092209900848
- Model number/lot numbers
- Amount recalled
- 1652 units in US; 4243 units OUS.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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