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Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP02512...

FDA Device Recall #Z-0243-2016 — Class II — October 23, 2015

Recall Summary

Recall Number Z-0243-2016
Classification Class II — Moderate risk
Date Initiated October 23, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Vascular, Inc.
Location Santa Rosa, CA
Product Type Devices
Quantity 1652 units in US; 4243 units OUS.

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.

Distribution Pattern

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. .

Lot / Code Information

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.

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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