Cala kIQ TLA-3268Recalls & reported problems
Cala Health, Inc. · Stimulator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851749007412), received between Jun 18, 2025 and Apr 1, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Atrial Fibrillation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Patient Device Interaction Problem
THE PATIENT REPORTED THAT APPROXIMATELY 30 MINUTES INTO A THERAPY SESSION, HE WENT INTO ATRIAL FIBRILLATION (AFIB). HE BEGAN TO FEEL CHEST DISCOMFORT FOLLOWED BY DIZZINESS AND DIFFICULTY WALKING, WHICH LED HIM TO DISCONTINUE THE SESSION. THE PATIENT STATED HE OBSERVED A RESTING HEART RATE OF 125 BPM AND "VERY HIGH" BLOOD PRESSURE.THE PATIENT CONSULTED A CARDIOLOGIST THE NEXT DAY, AND WAS PRESCRIBED A 14-DAY CARDIAC MONITOR FOR A SUSPECTED EPISODE OF ATRIAL FIBRILLATION (AFIB). CALA IS CURRENTLY IN COMMUNICATION WITH THE PATIENT TO OBTAIN THE NECESSARY SUPPLEMENTARY INFORMATION.
Patient problems: Atrial Fibrillation
MAUDE report 24758785 ↗InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
A HEALTHCARE PROVIDER'S OFFICE REPORTED THAT A PATIENT WAS HOSPITALIZED WITH AFIB REQUIRING A CARDIOVERSION AFTER USING THE DEVICE. THE PATIENT STOPPED USING THE DEVICE DUE TO THIS ISSUE. THE PATIENT'S SPOUSE REPORTED A HISTORY OF AFIB AND UNCERTAINTY ABOUT WHETHER THE RECENT EPISODE WAS CAUSED BY DEVICE USAGE. INITIALLY, THE PATIENT USED THE DEVICE REGULARLY WITHOUT ISSUE AND WISHED TO CONTINUE USE DUE TO FAVORABLE RESULTS WITH THE THERAPY, PENDING THE HEALTHCARE PROVIDER'S RECOMMENDATION. THE HEALTHCARE PROVIDER SUBSEQUENTLY RECOMMENDED THAT THE PATIENT RETURN THE DEVICE AND DISCONTINUE SERVICE. THE RETURN AND CANCELLATION WERE PROCESSED, AND THE SPOUSE WAS INFORMED ABOUT THE RETURN PROCESS.
Patient problems: Atrial Fibrillation
MAUDE report 22288053 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page