FDA Device recall Z-2522-2018
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System,…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System,… by Abbott Laboratories, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2522-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-14 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | n/a |
Product
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Reason
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.
Identifiers
| code_info | (a) Patient Electronics System, Model CM1100, UDI 05414734509800 Serial Numbers: P170102263 P170102267 P170202710…(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 P1708 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2018%22
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