Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Recalled by Abbott Laboratories, Inc. Due to Abbott is advising customers that a small number...
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 Abbott Laboratories, Inc. directly.
Affected Products
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Quantity: 2521 units
Why Was This Recalled?
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
Where Was This Sold?
US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
About Abbott Laboratories, Inc.
Abbott Laboratories, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report