St. Jude Medical: Medical Device Recall in 2023 - (Recall #: Z-1225-2023)

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

Class II

Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.

UDI/DI 05415067034724: M220200004, M220200005, M220200006, M220200008, M220200011, M220200014, M220200016, M220200017, M220200018, M220200019, M220200021, M220200022, M220200026, M220200028, M220200029, M220200031, M220200032, M220200034, M220200035, M220200036, M220200037, M220200039, M220200040, M220200041, M220200042, M220300002, M220300003, M220300004, M220300005, M220300007, M220300008, M220300009, M220300010, M220300011, M220300012, M220300013, M220300014, M220300016, M220300017, M220300018, M220300019, M220300021, M220300022, M220300023, M220300024, M220300025, M220300026, M220300027, M220300028, M220300029, M220300030, M220300031, M220300032, M220300035, M220300036, M220300040, M220300041, M220300042, M220300043, M220300044, M220300045, M220300046, M220300047, M220300048, M220300049, M220300050, M220300051, M220300052, M220300053, M220300054, M220300055, M220300057, M220300058, M220300059, M220300060, M220300061, M220300062, M220300063, M220300064, M220300065, M220300066, M220300067, M220300069, M220300070, M220300071, M220300073, M220300074, M220300075, M220300077, M220300078, M220300080, M220300081, M220300082, M220300083, M220300084, M220300085, M220300087, M220300088, M220300089, M220300091, M220300092, M220300093, M220300096, M220300097, M220300101, M220300102, M220300103, M220300104, M220300105, M220300107, M220300108, M220300109, M220300111, M220300112, M220300114, M220300115, M220300116, M220300118, M220300119, M220300120, M220300121, M220300122, M220300123, M220300125, M220300126, M220300127, M220300129, M220300131, M220300136, M220300138, M220300139, M220300140, M220300141, M220300142, M220300143, M220300144, M220300145, M220300146, M220300147, M220300150, M220300151, M220300152, M220300153, M220300154, M220300155, M220300156, M220300157, M220300158, M220300160, M220300161, M220300162, M220300163, M220300164, M220300166, M220300167, M220300168, M220300169, M220300170, M220300171, M220300172, M220300173, M220300174, M220300175, M220300176, M220300177, M220300178, M220300179, M220300180, M220300181, M220300182, M220300183, M220300184, M220300186, M220300187, M220300188, M220300189, M220300190, M220300191, M220300192, M220300193, M220300194, M220300195, M220300196, M220700025, M220700026, M220700027, M220700028, M220700031, M220700033, M220700034, M220700035, M220700036, M220700037, M220700041, M220700042, M220700043, M220700045, M220700051, M220700052, M220700054, M220700059, M220700061, M220700097, M220700098, M220700102, M220700104, M220700106, M220700107, M220700109, M220700110, M220700111, M220700112, M220700113, M220700114, M220700115, M220700116, M220700117, M220700118, M220700119, M220700120, M220700121, M220700122, M220700123, M220700124, M220700125, M220700126, M220700128, M220700129, M220700130, M220700131, M220700132, M220700133, M220700134, M220700135, M220700136, M220700137, M220700138, M220700139, M220700142, M220700143, M220700144, M220700145, M220700146, M220700147, M220900017, M220900018, M220900021, M220900023, M220900024, M220900025, M220900026, M220900030, M220900031, M220900032, M220900033, M220900034, M220900035, M220900037, M220900038, M220900040, M220900042, M220900044, M220900045, M220900046, M220900047, M220900048, M220900049, M220900050, M220900052, M220900063, M220900065, M220900066, M220900067, M220900068, M220900069, M220900070, M220900071, M220900072, M220900073, M220900075, M220900076, M220900078, M220900079, M220900080, M220900081, M220900086, M220900087, M220900088, M220900089, M220900090, M220900091, M220900093, M220900094, M220900095, M220900096, M220900097, M220900101, M220900104, M220900106, M220900109, M221000023, M221000030, M221000032, M221000034, M221000035, M221000038, M221000039, M221000041, M221000042, M221000044, M221000047, M221000048, M221000049, M221000050, M221000052, M221100002, M221000046

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

Voluntary: Firm initiated