The Recall Desk
HighFDA (Devices)·Z-1218-2023·Announced 2023-03-15

CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions

St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.

What this means for you

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 for a medical device with potential to cause electromagnetic interference with implanted life-critical devices such as pacemakers and cardiac defibrillators. No illnesses or injuries have been reported; the hazard is potential rather than confirmed, keeping this rating below Severe.

Plain-English summary

St. Jude Medical is recalling the CardioMEMS HF System Patient Electronics System (Model CM1000). The affected units include 3,177 devices with specific serial numbers beginning with M13, M14, and M15. These devices are implanted to monitor heart failure patients by measuring pulmonary artery pressure and guiding treatment decisions.

The CardioMEMS system emits radiofrequency energy that exceeds certain FDA emissions limits. When the device is actively taking pressure readings, these emissions have the potential to interfere with other medical devices in close proximity, including implantable pacemakers, implantable cardiac defibrillators, implantable neurostimulators, continuous glucose monitors, and bio-wearable sensors.

Patients with one of the affected CardioMEMS systems and other implanted medical devices should be aware of this potential interference risk. The affected devices have been distributed worldwide, including throughout the United States and other countries.

Patients should contact their physician or St. Jude Medical for guidance regarding their specific device and any precautions to take during readings or routine monitoring.

The recalled product

Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, 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 physicians
Manufacturer
St. Jude Medical
Category
Medical Device — Implantable Cardiac Monitor
Hazard
Affected units
3,177

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 05414734509169
  • Serial Numbers: M131100003
  • M131100004
  • M131100008
  • M131100012
  • M131100013
  • M131100015
  • M131200018
  • M131200022
  • M131200027
  • M131200030
  • M131200033
  • M131200034
  • M131200035
  • M131200036
  • M131200038
  • M131200040
  • M131200043
  • M131200044
  • M131200047

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 →

Related recalls

Same manufacturer · St. Jude Medical

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Same hazard · radiofrequency interference

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