Abbott recalls CardioMEMS HF System Patient Electronics (Model CM1100) and Hospital Electronics (Model CM3000) units that may display false Error 5 messages due to a configuration issue. Affected units have specific serial numbers listed in the recall.
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.
Abbott is recalling a small number of CardioMEMS HF System Patient Electronics (Model CM1100) and Hospital Electronics (Model CM3000) units that may display a false Error 5 message. This error is intended to indicate overheating but can occur incorrectly due to a device configuration issue. The recall does not pose a risk of injury but requires users to check if their unit is affected.
The system may display a false Error 5 message due to an incorrectly configured component within the device electronics. This error is intended to signal overheating but can occur incorrectly, potentially causing confusion about the device's status without causing physical harm.
Patients using the CardioMEMS HF System Patient Electronics (Model CM1100) or Hospital Electronics (Model CM3000) with specific serial numbers listed in the recall are affected. The risk is low as the error does not cause injury but may indicate a configuration issue.
Check if your CardioMEMS HF System has a Patient Electronics Model CM1100 or Hospital Electronics Model CM3000 with the serial numbers listed in the recall. The recall includes specific serial numbers starting with P170805 and M170908.
Compare your unit's serial number to the list of affected serial numbers provided in the recall.
No, the recall does not pose a risk of injury. The false Error 5 message is a configuration issue that does not cause physical harm but may indicate a need for verification.
Check your unit's serial number against the list of affected serial numbers provided in the recall, which includes models CM1100 and CM3000 with specific serial numbers starting with P170805 and M170908.
No action is required if your unit's serial number is not listed in the recall.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2522-2018 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2522-2018 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
