FDAFDA · Food and drugs·Recall number Z-2053-2017

HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

Published May 31, 2017 · Recall initiated: March 30, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Thoratec Corporation
Distributor: Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Lot: Serial Numbers PC-10255-B, PC-10329-B, PC-10357-B, PC-10476-B, PC-10478-B, PC-10486-B, PC-10518-B, PC-10519-B, PC-10524-B, PC-10525-B, PC-10538-B, PC-10540-B, PC-10544-B, PC-10626-B, PC-10629-B, PC-10973-C, PC-10976-C, PC-10977-C, PC-10986-C, PC-10988-C, PC-11017-C, PC-11018-C, PC-11019-C, PC-11027-C, PC-11041-C, PC-11044-C, PC-11050-C, PC-11055-C, PC-11056-C, PC-11063-C, PC-11068-C, PC-11073-C, PC-11077-C, PC-11082-C, PC-11083-C, PC-11085-C, PC-11086-C, PC-11090-C, PC-11104-C, PC-11105-C, PC-11106-C, PC-11136-C, PC-11142-C, PC-11150-C, PC-11151-C, PC-11152-C, PC-11156-C, PC-11163-C, PC-11164-C, PC-11168-C, PC-11200-C, PC-11209-C, PC-11228-C, PC-11231-C, PC-11233-C, PC-11234-C, PC-11236-C, PC-11237-C, PC-11239-C, PC-11240-C, PC-11246-C, PC-11248-C, PC-11249-C, PC-11251-C, PC-11253-C, PC-11255, PC-11256-C, PC-11258, PC-11261-C, PC-11262-C, PC-11263-C, PC-11264-C, PC-11265-C, PC-11268-C, PC-11270-C, PC-11272-C, PC-11273-C, PC-11275-C, PC-11276-C, PC-11278-C, PC-11279-C, PC-11282-C, PC-11283-C, PC-11340-C, PC-11343-C, PC-11349-C, PC-11351-C, PC-11352-C, PC-11353-C, PC-11357-C, PC-11361-C, PC-11373-C, PC-11378-C, PC-11379-C, PC-11380-C, PC-11382-C, PC-11389-C, PC-11390-C, PC-11391-C, PC-11392-C, PC-11393-C, PC-11394-C, PC-11396-C, PC-11397-C, PC-11398-C, PC-11404-C, PC-11414-C, PC-11417-C, PC-11419-C, PC-11422-C, PC-11428-C, PC-11432-C, PC-11436-C, PC-11437-C, PC-11439-C, PC-11443-C, PC-11455-C, PC-11456-C, PC-11457-C, PC-11459-C, PC-11468-C, PC-11469-C, PC-11474-C, PC-11476-C, PC-11477-C, PC-11481-C, PC-11489-C, PC-11495-C, PC-11497-C, PC-11499-C, PC-11500-C, PC-11501-C, PC-11502-C, PC-11506-C, PC-11507-C, PC-11508-C, PC-11509-C, PC-11510-C, PC-11511-C, PC-11518-C, PC-11519-C, PC-11520-C, PC-11532-C, PC-11536-C, PC-11541-C, PC-11542-C, PC-11547-C, PC-11551-C, PC-11552-C, PC-11553-C, PC-11554-C, PC-11559-C, PC-11560-C, PC-11572-C, PC-11576-C, PC-11579-C, PC-11583-C, PC-11596-C, PC-11597-C, PC-11598-C, PC-11603-C, PC-11607-C, PC-11614-C, PC-11632-C, PC-11637-C, PC-11638-C, PC-11642-C, PC-11656-C, PC-11673-C, PC-11690-C, PC-11693-C, PC-11694-C, PC-11695-C, PC-11701-C, PC-11704-C, PC-11706-C, PC-11707-C, PC-11714-C, PC-11716-C, PC-11717-C, PC-11723-C, PC-11724-C, PC-11727-C, PC-11729-C, PC-11734-C, PC-11736-C, PC-11739-C, PC-11740-C, PC-11741-C, PC-11744-C, PC-11745-C, PC-11746-C, PC-11747-C, PC-11749-C, PC-11771-C, PC-11773-C, PC-11775-C, PC-11776-C, PC-11777-C, PC-11780-C, PC-11790-C, PC-11793-C, PC-11794-C, PC-11796-C, PC-11797-C, PC-11798-C, PC-11801-C, PC-11803-C, PC-11804-C, PC-11810-C, PC-11812-C, PC-11816-C, PC-11819-C, PC-11842-C, PC-11869-C, PC-11886-C, PC-11888-C, PC-11889-C, PC-11905-C, PC-11907-C, PC-11909-C, PC-11910-C, PC-11913-C, PC-11915-C, PC-11918-C, PC-11922-C, PC-11923-C, PC-11927-C, PC-11928-C, PC-11929-C, PC-11930-C, PC-11931-C, PC-11939-C, PC-11940-C, PC-11988, PC-11993, PC-11997, PC-11998, PC-12002, PC-12003, PC-12004, PC-12005, PC-12006, PC-12009, PC-12017, PC-12018, PC-12019, PC-12020, PC-12021, PC-12029, PC-12034, PC-12036, PC-12038, PC-12040, PC-12041, PC-12047, PC-12049, PC-12053, PC-12054, PC-12063, PC-12067, PC-12068, PC-12076, PC-12077-D, PC-12078, PC-12081, PC-12083, PC-12087, PC-12091, PC-12092, PC-12093, PC-12096, PC-12098, PC-12101, PC-12108, PC-12111, PC-12113, PC-12115, PC-12118, PC-12121, PC-12123, PC-12131, PC-12136, PC-12145, PC-12148, PC-12154, PC-12155, PC-12158, PC-12159-D, PC-12160, PC-12165, PC-12166, PC-12168, PC-12169, PC-12171, PC-12175, PC-12176, PC-12177, PC-12181, PC-12183, PC-12184, PC-12185, PC-12187, PC-12190, PC-12203, PC-12207, PC-12209, PC-12211, PC-12216, PC-12218, PC-12219, PC-12221, PC-12222, PC-12227, PC-12229, PC-12230, PC-12231, PC-12232, PC-12235, PC-12237, PC-12239, PC-12241, PC-12242, PC-12243, PC-12253, PC-12256, PC-12258, PC-12265, PC-12266, PC-12269, PC-12270, PC-12272, PC-12273, PC-12274, PC-12276, PC-12283-E, PC-12296-E, PC-12304, PC-12305, PC-12306, PC-12307, PC-12308, PC-12310, PC-12312-E, PC-12313-E, PC-12335, PC-12339, PC-12340, PC-12341, PC-12343, PC-12344
Risk classification: Class I
Area (FDA): device
Country: United States

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