The Recall Desk
HighFDA (Devices)·Z-1225-2023·Announced 2023-03-15

CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations

St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.

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 medical device recall with no reported illnesses or injuries. The hazard is a risk-of-harm scenario: operating outside intended radiofrequency range could cause inaccurate heart failure pressure readings, but injury has not yet occurred. This matches the rubric criterion for 'High' severity.

Plain-English summary

St. Jude Medical is recalling select CardioMEMS PA Sensors (Model CM2000) due to a potential frequency-range issue at high elevations. A total of 317 units are affected.

The CardioMEMS system monitors pulmonary artery pressure to help physicians manage heart failure treatment. At elevations above approximately 2,000 feet (610 meters) above sea level, affected sensors may operate outside their intended radiofrequency range, potentially causing inaccurate readings or difficulty acquiring sensor signals.

The recall affects devices distributed worldwide, including throughout the United States and in 22 countries including Canada, the United Kingdom, France, Germany, Australia, and others. Patients with affected CardioMEMS sensors should verify their device serial number against the FDA's list of affected units.

If your device is among those recalled, contact your healthcare provider immediately. Your physician will determine whether your sensor needs replacement or if additional monitoring is necessary. Do not attempt to remove or repair the device yourself. Continue using your system as directed unless instructed otherwise by your physician.

The recalled product

Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, 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 use
Manufacturer
St. Jude Medical
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
317

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 05415067034724: M220200004
  • M220200005
  • M220200006
  • M220200008
  • M220200011
  • M220200014
  • M220200016
  • M220200017
  • M220200018
  • M220200019
  • M220200021
  • M220200022
  • M220200026
  • M220200028
  • M220200029
  • M220200031
  • M220200032
  • M220200034
  • M220200035
  • M220200036

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

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Same hazard · inaccurate readings

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