The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1220-2023·Announced 2023-03-15

CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions

CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.

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: This is a Class II FDA recall involving a risk-of-harm product. No illnesses or injuries have been reported. The hazard—potential electromagnetic interference with critical implanted devices like pacemakers and defibrillators—is theoretical but poses significant risk. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The CardioMEMS HF System Patient Electronics System (PES) Model CM1100 is being recalled by St. Jude Medical. The device emits radiofrequency (RF) energy that exceeds established regulatory limits.

The excessive RF emissions have the potential to cause interference with other medical devices, including implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, and bio-wearable sensors when those devices are in close proximity during active CardioMEMS readings.

The CardioMEMS system is used for monitoring and managing heart failure by measuring pulmonary artery pressure. Approximately 34,905 units have been distributed worldwide across multiple countries including the United States.

The recalled product

Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Manufacturer
St. Jude Medical
Category
Medical Device — Cardiac Monitoring System
Hazard
Affected units
34,905

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)

  • UDI/DI 05414734509800
  • Serial Numbers: P150800220
  • P150800221
  • P150800222
  • P150800224
  • P150800226
  • P150800227
  • P150800228
  • P150800240
  • P150800241
  • P150800242
  • P150800243
  • P150800244
  • P150800245
  • P150800246
  • P150800249
  • P150800262
  • P150800263
  • P150800264
  • P150800265

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by St. Jude Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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