Recall Z-2522-2018 ยท MOM System, Hemodynamic, Implantable
Abbott Laboratories, Inc.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
| Date | Jun 14, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2521 units |
| Distribution | US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.