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.
Enforcement
- Recall Number
- Z-1225-2023
- Event ID
- 91606
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- St. Jude Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Classification Date
- March 6, 2023
- Address
- 387 Technology Cir Nw Ste 500, Atlanta, GA, 30313-2424, United States
Description
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.
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.
317 units