CardioMEMS Patient Electronic System power connector damage risk
St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a cardiac monitoring device for a potential electrical hazard. This qualifies as a risk-of-harm product where no injuries have been reported; a failed power connector could impair critical cardiac monitoring function in patients dependent on this device.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS Patient Electronic System (PES), Model Number CM1100, used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate. Approximately 36,153 units have been distributed worldwide to patients in the United States and 20 additional countries.
The recall was initiated because the power connector plug may become damaged and frayed if bent or manipulated beyond 90 degrees. A damaged or frayed connector could create an electrical hazard or prevent the device from functioning properly, affecting the patient's ability to continuously monitor their cardiac condition.
Patients using an affected device should contact their healthcare provider or St. Jude Medical immediately if they observe any visible damage to the power connector. Patients should discontinue use of any device with a visibly damaged connector and request a replacement from their healthcare provider.
The recalled product
- Product
- CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
- Manufacturer
- St. Jude Medical
- Affected units
- 36,153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number CM1100
- UDI/DI: 05414734509800
- Serial Numbers: P150800220
- P150800222
- P150800226
- P150800240
- P150800242
- P150800245
- P150800246
- P150800249
- P150800262
- P150800263
- P150800264
- P150800265
- P150800266
- P150800267
- P150800268
- P150800273
- P150800277
- P150900313
Distribution
Distributed nationwide across the United States.
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