Kardia Mobile AC-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B210AC0090), received between May 22, 2020 and Jul 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2020Incorrect, Inadequate or Imprecise Result or Readings

  USER CONTACTED ALIVECOR ON (B)(6) 2020 STATING THAT HE USED HIS KARDIAMOBILE 1L TO TAKE AN EKG AND RECEIVED A NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENTS FROM THE PATIENT NOTES THAT "STILL RECOVERING FROM HEART ATTACK ON (B)(6). I USED THIS DEVICE 2 MINUTES PRIOR TO CALLING AMBULANCE AND DEVICE SAID EVERYTHING WAS FINE WITH MY HEART. SUFFERED MAJOR HEART ATTACK THAT MORNING."

  Patient problems: Myocardial Infarction

  MAUDE report 10217486 ↗
• InjuryMay 22, 2020Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT CONTACTED ALIVECOR ON (B)(6) 2020 STATING THAT SHE USED KARDIAMOBILE TO TAKE EKG AND RECEIVED NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENTS FROM THE PATIENT NOTES THAT "ON (B)(6), I STARTED HAVING CHEST PAIN, LEFT ARM/SHOULDER PRESSURE/PAIN, NECK AND JAW PAIN. I HAD NOT USED THE KARDIA UNIT IN A WHILE AND HAD TO UPDATE THE APP ON MY PHONE. AFTER MORE THAN FEW ATTEMPTS I GOT A READING THAT SAID NORMAL EKG."

  Patient problems: Chest Pain; Myocardial Infarction; Neck Pain

  MAUDE report 10084224 ↗