FDA Enforcement Class II Terminated

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

Recall: Z-0243-2016 · Reported November 18, 2015

Enforcement

Recall Number: Z-0243-2016
Event ID: 72502
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Medtronic Vascular, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: November 18, 2015
Initiation Date: October 23, 2015
Classification Date: November 6, 2015
Termination Date: July 31, 2017
Address: 3576 Unocal Pl, N/A, Santa Rosa, CA, 95403-1774, United States

Description

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.

Code Info

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.

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 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. .

Quantity

1652 units in US; 4243 units OUS.