Thymatron IV System IVRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850298007003), received between Feb 25, 2020 and Nov 7, 2022 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  LAWSUIT WAS FILED IN CALIFORNIA CLAIMING MANY SERIOUS INJURIES INCLUDING BRAIN DAMAGE, MEMORY LOSS AND OTHER PROBLEMS. DATES OF TREATMENTS WERE OVER FOUR YEARS AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745876 ↗
• InjurySep 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  AS AN ETHICAL MANDATED REPORTER, IN AN EFFORT TO CLOSE THE GAP BETWEEN PUBLISHED RESEARCH AND FDA ACKNOWLEDGED RISKS (SINCE THE FDA ALLOWED MANUFACTURERS TO MARKET THIS DEVICE WITHOUT PMA OR PDP). IN HUMAN EXPERIMENTATION USING HEURISTIC ELECTRICAL DOSING PARAMETERS WITH NO CLINICAL OR SCIENTIFIC RATIONALE WITHOUT THE KNOWLEDGE OF THE PATIENT OR THEIR LOVED ONES, I FEEL IT IS NECESSARY TO SUBMIT THIS ARTICLE ON BEHALF OF THE CASE-STUDY AUTHORS (DOI: 10.1186/S40981-020- 00389-6) A 66-YEAR-OLD, 57 KG, WOMAN WITH BIPOLAR DISORDER WAS SCHEDULED FOR MAINTENANCE ECT. SHE HAD BEEN DIAGNOSED WITH BIPOLAR DISORDER OVER 9 YEARS EARLIER. SHE HAD UNDERGONE 12 SESSIONS OF ECT UNDER GENERAL ANESTHESIA IN OUR HOSPITAL. PROPOFOL AND SUXAMETHONIUM WERE USED FOR GENERAL ANESTHESIA IN EVERY ECT PROCEDURE. ECT WAS EFFECTIVE AGAINST THE BIPOLAR DISORDER, AND SHE HAD ACHIEVED EXCELLENT. CLINICAL RESPONSE WITH MAINTENANCE ECT EVERY 2¿3 MONTHS OVER 9 YEARS IN OUR HOSPITAL. WITH OVER 100 SESSIONS OF ECT DURING THE 9 YEARS, NO ADVERSE HEMODYNAMIC EVENTS OF NOTE (INCLUDING BRADYCARDIA). HAD BEEN OBSERVED, AND NO ATROPINE HAD BEEN ADMINISTERED AT ANY SESSION OF ECT IN OUR HOSPITAL. IN ADDITION, ECT PROCEDURES

  Patient problems: Tachycardia

  MAUDE report 15383621 ↗
• InjurySep 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IN AN EFFORT TO CLOSE THE GAP BETWEEN REAL WORLD OUTCOMES AND THOSE ACKNOWLEDGED BY THE FDA, DEVICE MANUFACTURERS, HOSPITALS AND DOCTORS, THIS REPORT IS SUBMITTED AS MY DUTY AS A MANDATED REPORTER, DRAWING DATA FROM PUBLISHED A CASE REPORT (DOI: 10.3389/FPSYT.2022.899847) A CASE REPORT OF LEUKOCYTOSIS DURING MODIFIED ELECTROCONVULSIVE THERAPY OF PARANOID PERSONALITY DISORDER. FRONT. PSYCHIATRY 13:899847. ON (B)(6) 2018, BEFORE THE PATIENT RECEIVED MECT FOR THE FIRST TIME, WE CONDUCTED REGULAR LABORATORY EXAMINATION DURING HOSPITALIZATION, WHICH SHOWED THAT THE PATIENT'S BLOOD CELL COUNT, LIVER FUNCTION AND RENAL FUNCTION WERE NORMAL. BEFORE MECT, WE ONCE AGAIN MONITORED THE VITAL SIGNS OF THE PATIENT, BODY TEMPERATURE: 36.3 DEGREES CELSIUS, PULSE: 78 TIMES/MIN, BLOOD PRESSURE: 110/66 MMHG, USED THYMATRON, THE INTERNAL OUTPUT VOLTAGE IS 450 V AND THE OUTPUT CURRENT IS 900 MA. WHEN STARTING THE TREATMENT, THE ENERGIZING ENERGY WAS 20% J, BECAUSE OF UNSTABLE CURRENT DURING THE TREATMENT PROCESS, THE INSTRUMENT AUTOMATICALLY ADJUSTED THE CURRENT TO 920 MA, AND THE ENERGIZING TIME WAS 5.6 S. DURING AND AFTER MECT, THE PATIENT HAD VERY SLIGHT AND UNSUSTAINABLE LIMB VIBRATION LASTED NEARL

  Patient problems: Alteration in Body Temperature

  MAUDE report 15383616 ↗
• InjurySep 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  AS AN ETHICAL MANDATED REPORTER, I SUBMIT THIS ON BEHALF OF THE AUTHORS OF A RESEARCH STUDY PUBLISHED IN THE JOURNAL OF ECT DOI: 10.1097/YCT.0B013E318255A8D4. DURING HIS THIRD TREATMENT, THE STIMULUS DOSE WAS AGAIN 30%, RESULTING IN A MOTOR SEIZURE LASTING 29 SECONDS AS CONFIRMED BY VISUAL INSPECTION AND SURFACE ELECTROMYOGRAM OF THE CUFFED RIGHT FOOT. THE EEG SEIZURE WAS DETERMINED FROM A SINGLE CHANNEL OF EEG (FP1-M1) AND LASTED APPROXIMATELY 85 SECONDS, BUT THE ENDING WAS INDETERMINATE WITH POOR POSTICTAL SUPPRESSION BY VISUAL INSPECTION. THE EEG RECORDING WAS CONTINUED FOR AN ADDITIONAL 51 SECONDS TO 136 SECONDS WITH NO FURTHER EEG SUPPRESSION. THE COMPUTERIZED THYMATRON ANALYSIS OF POSTICTAL SUPPRESSION YIELDED A RESPONSE OF ''N/A.'' OWING TO A PEAK INTERICTAL BLOOD PRESSURE OF 170 SYSTOLIC, HE RECEIVED 600 KG OF NITROGLYCERIN. THE PATIENT INITIALLY SEEMED TO RECOVER SPONTANEOUSLY FROM ECT, WITH STABLE HEMODYNAMICS AND NORMAL RESPIRATIONS. FIFTY-FIVE MINUTES AFTER THE STIMULUS, THE POSTANESTHESIA CARE NURSE NOTED THAT HE WAS NOT RESPONDING APPROPRIATELY TO QUESTIONING. HE WAS ASKED IF HE WANTED A DRINK OF WATER TO WHICH HE WAS ABLE TO ANSWER ''YES'' BUT PROVIDED NOTHING MORE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383562 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem

  THE CLAIMANT FILED A LAWSUIT CLAIMING MULTIPLE INJURIES INCLUDING BRAIN DAMAGE AND MEMORY ISSUES.

  Patient problems: Brain Injury; Memory Loss/Impairment

  MAUDE report 11572222 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem

  MANY SERIOUS INJURIES WERE CLAIMED.

  Patient problems: Injury

  MAUDE report 10032208 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem

  COMPLAINANT DESCRIBED MULTIPLE INJURIES INCLUDING BRAIN DAMAGE, NEUROCOGNITIVE INJURIES, PERMANENT MEMORY LOSS AND SEVERAL OTHERS. THIS WAS WRITTEN IN A LAWSUIT FILED BY THE COMPLAINANT. THERE WERE NO SUPPORTING DOCUMENTS, MEDICAL RECORDS OR HEALTH PROFESSIONAL REPORTS PROVIDED.

  Patient problems: Brain Injury; Cognitive Changes; Memory Loss/Impairment

  MAUDE report 9752278 ↗