CardioMEMS HF System PA Sensor and Delivery System recall
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used…
Why was CardioMEMS HF System PA Sensor and Delivery System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used…
- Recalling firm
- St. Jude Medical
- Quantity
- 317 units
- Distribution
- 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.
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)