Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CardioMEMS Patient Electronic System (PES) Recalled by St. Jude Medical Due to Potential for damaged and frayed power connector plug...

Date: October 4, 2023
Company: St. Jude Medical
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical directly.

Affected Products

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

Quantity: 36,153 units

Why Was This Recalled?

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About St. Jude Medical

St. Jude Medical has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report