CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System
Medical device recall Z-2522-2018. Published in FDA’s Enforcement Report on Aug 1, 2018.
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 Aug 1, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2521 units 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?
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
2521 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) Patient Electronics System, Model CM1100, UDI 05414734509800 Serial Numbers: P170102263 P170102267 P170202710 P170604856 P170704970 P170805650 P170805651 P170805652 P170805653 P170805654 P170805655 P170805656 P170805657 P170805658…
Every code shown here, 1,995 characters
(a) Patient Electronics System, Model CM1100, UDI 05414734509800 Serial Numbers: P170102263 P170102267 P170202710 P170604856 P170704970 P170805650 P170805651 P170805652 P170805653 P170805654 P170805655 P170805656 P170805657 P170805658 P170805659 P170805660 P170805661 P170805662 P170805663 P170805664 P170805665 P170805666 P170805667 P170805668 P170805669 P170805670 P170805671 P170805672 P170805673 P170805674 P170805675 P170805676 P170805677 P170805679 P170805681 P170805682 P170805683 P170805684 P170805685 P170805687 P170805688 P170805689 P170805690 P170805691 P170805692 P170805693 P170805694 P170805695 P170805696 P170805697 P170805698 P170805700 P170805701 P170805702 P170805703 P170805704 P170805705 P170805706 P170805707 P170805708 P170805709 P170805710 P170805711 P170805712 P170805713 P170805715 P170805716 P170805717 P170805719 P170805720 P170805721 P170805722 P170805723 P170805725 P170805726 P170805727 P170805728 P170805729 P170805730 P170805733 P170805734 P170805736 P170805737 P170805738 P170805739 P170805740 P170805741 P170805742 P170805743 P170805744 P170805745 P170805746 P170805747 P170805748 P170805750 P170805752 P170805753 P170805754 P170805755 P170805756 P170805757 P170805758 P170805760 P170805761 P170805762 P170905764 P170905765 P170905767 P170905768 P170905770 P170905771 P170905772 P170905773 P170905774 P170905776 P170905777 P170905778 P170905779 P170905780 P170905781 P170905782 P170905783 P170905784 P170905785 P170905786 P170905787 P170905788 P170905790 P170905791 P170905792 P170905793 P170905794 P170905795 P170905796 P170905797 P170905798 P170905799 P170905800 P170905802 P170905803 P170905804 P170905805 P170905806 P170905807 P170905809 P170905810 P170905812 P170905813 P170905814 P170905815 P170905817 P170905818 P170905819 P170905820 P170905821 P170905822 P170905823 P170905824 P170905825 P170905826 P170905828 P170905829 P170905830 P170905831 P170905832 P170905833 P170905834 P170905835 P170905836 P170905837 P170905838 P170905839 P170905840 P170905841…
FDA’s list runs to 27,893 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.
US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Jun 14, 2018.
- FDA classified it on Jul 20, 2018.
- FDA’s Enforcement Report published it on Aug 1, 2018.
- FDA terminated it on Sep 8, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, Inc., 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 27,893 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.