Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CardioMEMS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall CardioMEMS see related information
Date Initiated by Firm February 07, 2023
Date Posted March 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1225-2023
Recall Event ID 91606
PMA Number P100045 
Product Classification System, hemodynamic, implantable - Product Code MOM
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 St. Jude Medical
387 Technology Cir Nw Ste 500
Atlanta GA 30313-2424
For Additional Information Contact Mr. Justin Paquette
651-756-6293
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action Abbott notified consignees on about 02/07/2023 via hand-delivery of the letter within the US. The letter instructed consignees to do the following: 1. Prior to the implantation procedure, sensor data should be entered, and the clinician should proceed to the next screen to complete the Error #8 screening, prior to venipuncture. 2. If an Error #8 message occurs, the sensor should not be implanted. 3. Work with your Abbott Sales Representative to exchange the affected sensor. 4. Review Appendix B for labeling and supplemental information related to implantation and monitoring of CardioMEMS PA Sensors.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MOM and Original Applicant = Abbott Medical
-
-