Recall Z-0218-2024— St. Jude Medical
Class II · Ongoing
Class II FDA medical device recall by St. Jude Medical, initiated 2023-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.. Reason: Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees..
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-04
- Firm location
- Atlanta, GA, United States
Product description
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Reason for recall
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Data sourced from openFDA. This site is unofficial and independent of the FDA.