Recall Z-2522-2018
Abbott Laboratories, Inc. · initiated June 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Codes / lots: (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…
Reason for recall
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-determined cause: Process control
Action taken
The firm notified the hospital and clinics of the recall on 06/14/2018 and the patients on 06/15/2018 by letter. The letter explained that the units 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. The firm is requesting return of the units. Patients may contact Abbott Remote Care Technical Support at 1-844-692-6367 for assistance and further information.
Details
- Recall number
- Z-2522-2018
- Initiated
- June 14, 2018
- Terminated
- September 8, 2021
- Product code
- MOM – System, Hemodynamic, Implantable
- Quantity
- 2521 units
- Distribution
- US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
- Recalling firm
- Abbott Laboratories, Inc., Atlanta, GA