Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2522-2018 — CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

U.S. FDA — Device Enforcement · United States · 2018-06-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2522-2018
Date of alert
2018-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05414734509800
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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