Recall Z-0218-2024 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
| Date | Nov 3, 2023 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| Reason | Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. |
| Root cause | Device Design |
| Action | Abbott notified clinics on about 10/04/2023 via hand delivery of IMPORTANT MEDCIAL DEVICE CORRECTION letter. Clinics were instructed to continue following the IFU and also the supplemental guidance in the letter to continue taking readings as your Health Care Professional has recommended, inspect the Power Connector Plug for damage prior to taking your next reading, if you suspect or identify damage to the power connector plug or any other issues, call Abbott Technical Support, and after the initial inspection, Abbott requests that each Patient Electronics System power connector plug is inspe |
| Quantity | 36,153 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NETHERLANDS, PORTUGAL, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.