Cardio Clear Z100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814907020265), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fire” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103159); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2022Fire

  DURING CARDIOVERSION PROCEDURE, WHEN PHYSICIAN PRESSED BUTTON TO DEFIB PATIENT, THE DEFIB CARDIO CLEAR PAD IGNITED IN FLAMES WHICH CAUGHT SURROUNDING BEDDING AND OXYGEN MASK TO ALSO IGNITE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15551194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103159. One submission often covers many models, so check the product and lot details in each record.

• Z-1669-2013 · Apr 26, 2013 · Terminated
  Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385