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.

Detalles del retiro

Fabricante

Thoratec Corporation

Distribuidor

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.

Lote

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

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States