CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System
Medical device recall Z-1427-2025. Published in FDA’s Enforcement Report on Apr 2, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 2, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 46 states named
- 193 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS” HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
193 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 Population 1 Serial Numbers: M220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿…
Every code shown here, 1,990 characters
UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 Population 1 Serial Numbers: M220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿ M240100040 In addition, 4 CM3100 have no serial number and are located at Treating Clinic Population 2: Serial Numbers: M220300029 M220300031 M220300041 M220300069 M220300079 M220300113 M220300162 M220700130 M220700131 M220700140 M220900031 M220900038 M220900109 M221000019 M221100013 M230200053 M230500034 M230900025 M231100031 M231100057 M240100066 M240100074 M240500083 In addition, seven device with no serial number - located at Treating or Consulting Clinic Population 3: Serial Numbers: M220200009 M220200013 M220200022 M220200045 M220300001 M220300003 M220300005 M220300007 M220300010 M220300016 M220300019 M220300034 M220300036 M220300045 M220300047 M220300048 M220300061 M220300076 M220300078 M220300081 M220300085 M220300089 M220300090 M220300093 M220300098 M220300110 M220300112 M220300118 M220300128 M220300129 M220300133 M220300152 M220300155 M220300157 M220300160 M220300161 M220300166 M220700030 M220700032 M220700043 M220700044 M220700051 M220700057 M220700062 M220700065 M220700078 M220700084 M220700091 M220700101 M220700106 M220700119 M220700121 M220700134 M220700138 M220700141 M220900021 M220900028 M220900032 M220900040 M220900041 M220900044 M220900074 M220900078 M220900082 M220900087 M220900093 M220900096 M220900103 M220900113 M220900122 M220900123 M221000014 M221000015 M221000022 M221000029 M221000045 M221100010 M221100016 M221100026 M221100045 M221100048 M221100057 M221100066 M230100006 M230100017 M230200020 M230200034 M230200036 M230200041 M230200046 M230200066 M230200072 M230200073 M230300004 M230300010 M230300012 M230300013 M230300025 M230300034 M230300043 M230400005 M230400012 M230400018 M230400019 M230400021 M230400022 M230400023 M230400025 M230400029 M230400031 M230400032 M230400039 M230400041 M230400043 M230400050…
FDA’s list runs to 2,637 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA WI, and WV.
The states and territories these words name
46 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 3, 2025.
- FDA classified it on Mar 21, 2025.
- FDA’s Enforcement Report published it on Apr 2, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St. Jude Medical, of Atlanta, GA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,637 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.