CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Reported: November 15, 2023 Initiated: October 4, 2023 #Z-0218-2024
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.
Details
- Recalling Firm
- St. Jude Medical
- Units Affected
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.. Recalled by St. Jude Medical. Units affected: 36,153 units.
Why was this product recalled? ▼
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0218-2024.
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