CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary art
Summary
The FDA issued a Class II for CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The Car by St. Jude Medical. Reason: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approxim.
Details
Source
Device Recall
External ID
Z-1225-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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
Quantity Affected: 317 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-07
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
St. Jude Medical has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical have FDA actions?
St. Jude Medical has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1225-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29