Confirm Rx™ DM3500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,149 adverse event reports that list this exact device (DI 05415067027320), received between Jan 25, 2018 and Sep 10, 2026 — classified as 2 deaths, 682 injuries, 4,465 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (2,560 reports).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. Apr 16, 2018Terminated

   The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

   Z-2334-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 13, 2018Terminated

   Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.

   Z-0808-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,149 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort

  MAUDE report 50703257 ↗
• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the patient presented for a follow-up in clinic. It was noted that the implantable cardiac monitor (ICM) sent a tachycardia episode alert, but the corresponding electrograms (EGMs) were unavailable. No intervention or changes were reported, the ICM remains implanted. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491821 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic due to skin discomfort at the implant site. As a result, the implantable cardiac monitor was explanted. The patient remained stable throughout the procedure.

  Patient problems: Discomfort

  MAUDE report 50078943 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SKIN DISCOMFORT. THE INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 24934023 ↗
• MalfunctionApr 15, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP CLINIC VISIT. UPON INTERROGATION, IT WAS OBSERVED THAT THE INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED INVALID CHARACTERS ON THE EPISODE SUMMARY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883508 ↗
• InjuryApr 3, 2026Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784135 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED DUE TO PATIENT EXPERIENCE DISCOMFORT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 24613362 ↗
• MalfunctionFeb 27, 2026Failure to Interrogate; No Apparent Adverse Event

  NEW INFORMATION RECEIVED NOTES THAT THE INSERTABLE CARDIAC MONITOR EXHIBITED LOSS OF BLUETOOTH TELEMETRY DUE TO NORMAL LOW BATTERY, AND THE DEVICE WAS PERFORMING NORMAL FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466630 ↗
• InjuryFeb 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYMPTOMS OF SKIN DISCOMFORT CAUSED BY THE IMPLANTABLE CARDIAC MONITOR (ICM). THE ICM WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 24288529 ↗
• InjuryFeb 5, 2026Failure to Interrogate

  ADDITIONAL INFORMATION RECEIVED INDICATED THE ICM WAS EXPLANTED AND REPLACED. IT WAS STATED THE BATTERY WAS DEPLETED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270116 ↗
• MalfunctionJan 28, 2026Insufficient Device Problem Information; Interrogation Problem

  IT WAS REPORTED THAT A PATIENT'S INSERTABLE CARDIAC MONITOR WAS UNABLE TO SEND A REMOTE TRANSMISSION DUE TO UNSPECIFIED OUT OF RANGE PARAMETERS. IN THE FOLLOWING DAYS, ANOTHER TRANSMISSION WAS SUCCESSFULLY SENT AND PARAMETERS SHOWED WITHIN NORMAL LIMITS. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205567 ↗
• MalfunctionJan 23, 2026Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORETED THAT THE IMPLANTABLE CARDIAC MONITOR WAS UNABLE TO COMPLETE A DEVICE CHECK. IT WAS NOTED THAT THE DEVICE MAYBE BE AT END OF SERVICE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171983 ↗
• MalfunctionDec 30, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930750 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP EXPERIENCING SKIN DISCOMFORT DUE TO THE IMPLANTABLE CARDIAC MONITOR (ICM). THE ICM WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 23824443 ↗
• MalfunctionDec 16, 2025Failure to Interrogate; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW-UP, IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE WITH BLUETOOTH TELEMETRY. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820437 ↗
• MalfunctionNov 21, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED ON THE DEVICE. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622204 ↗
• MalfunctionNov 3, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452761 ↗
• MalfunctionOct 27, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED LOSS OF BLUETOOTH TELEMETRY. ADDITIONALLY, NO MAGNET RESPONSE WAS RECEIVED. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390610 ↗
• MalfunctionOct 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED DURING REMOTE FOLLOW-UP, A PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) WAS INTERROGATED VIA BLUETOOTH TELEMETRY, AND THE ICM WAS NOT ABLE TO RETRIEVE ELECTROGRAM (EGM) AND WOULD BE STUCK AT LOADING. THE EGM WAS RETRIEVED VIA MERLIN.NET REMOTE MONITORING FOR REVIEW EVENTUALLY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343453 ↗
• MalfunctionOct 19, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333666 ↗
• InjurySep 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN-CLINIC FOLLOW-UP, AN ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT WAS RECEIVED ON THE DEVICE. PREMATURE BATTERY DEPLETION IS SUSPECTED, ALTHOUGH NOT CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058265 ↗
• InjurySep 4, 2025Failure to Interrogate; Failure to Interrogate

  DURING AN IN-CLINIC FOLLOW-UP, IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE USING BLUETOOTH (BLE) TELEMETRY. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963835 ↗
• MalfunctionAug 21, 2025Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED ON THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT YET AVAILABLE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED; THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869050 ↗
• MalfunctionJul 31, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED EPISODES OF UNDER-SENSING WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680480 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT DURING EXPLANT, THE DEVICE BROKE INTO TWO PIECES. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571547 ↗