Iforia 7 DR-T DF-1 US 390064Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04035479126926), received between Dec 13, 2017 and Dec 3, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (9 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  THIS DEVICE WAS EXPLANTED DUE TO EOS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704987 ↗
• MalfunctionJun 3, 2024Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454914 ↗
• MalfunctionAug 18, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571987 ↗
• MalfunctionJun 28, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator

  THIS DEVICE WAS EXPLANTED DUE TO EOS WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218035 ↗
• MalfunctionMay 26, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE IS AT ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED AT THIS TIME. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516100 ↗
• MalfunctionDec 22, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  HOME MONITORING REPORTED ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE CURRENTLY REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060703 ↗
• MalfunctionAug 29, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator

  DEVICE EXPLANTED DUE TO EOS. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381503 ↗
• MalfunctionApr 28, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736795 ↗
• MalfunctionDec 29, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THAT THIS DEVICE REACHED ERI. THE MANUFACTURERS ANALYSIS REVEALED A BATTERY ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087516 ↗
• MalfunctionDec 8, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THAT THE BATTERY WAS MOL 1 IN OCTOBER (APPROXIMATELY 50 PERCENT BATTERY REMAINING) AND ON (B)(6) 2020 THERE WAS A HOME MONITORING ALERT FOR ERI. DATA ANALYSIS REVEALED A BATTERY ISSUE. DEVICE REMAINS IMPLANTED, NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972123 ↗
• MalfunctionDec 5, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THAT THIS DEVICE REACHED ERI ON (B)(6) 2020. PREVIOUS IN OFFICE INTERROGATION ON 2020 SHOWED 42 PERCENT BATTERY REMAINING. DATA ANALYSIS REVEALED AN UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953616 ↗
• MalfunctionOct 22, 2020Failure to Interrogate; Failure to Interrogate

  PATIENT RECEIVED A SHOCK ON 10/19, DEVICE DID NOT TRANSMIT VIA HOME MONITORING ON THE MORNING OF 10/20 EVEN THOUGH HE WAS BY HIS MONITOR. PATIENT CAME INTO CLINIC ON 10/20 FOR DEVICE INTERROGATION, AND DEVICE WAS UNABLE TO BE INTERROGATED THROUGH SEVERAL PROGRAMMERS. DUE TO THIS DEVICE BEHAVIOR IT WAS DECIDED THAT THE GENERATOR NEEDED TO BE EXPLANTED. DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10720979 ↗
• MalfunctionOct 2, 2020Battery Problem; Battery Problem

  IT WAS REPORTED ON (B)(6) 2019 THAT THIS DEVICE HAD 63 PERCENT BATTERY IN APRIL AND IS NOW ERI. NO SETTINGS OR PROGRAMMING CHANGES THAT COULD HAVE CONTRIBUTED TO THE ERI STATUS. THE DEVICE IS ONLY PACING VERY INFREQUENTLY, DOES NOT SEEM TO BE DRAWING FROM THE BATTERY FREQUENTLY. PATIENT REPORTED THAT DEVICE FEELS FUNNY, POSSIBLY THE POCKET IS TOO LARGE AND DEVICE IS MIGRATING. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10623748 ↗
• MalfunctionNov 14, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator

  PATIENT UNDERWENT AN MR SCAN WITHOUT BEING PROGRAMMED TO AN MRI MODE. THE DEVICE SUBSEQUENTLY WENT EOS. PER HM, THE BATTERY VOLTAGE WAS 3.08 V ON (B)(6) 2019. DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9322124 ↗
• MalfunctionJun 2, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  HOME MONITORING ALERTED THAT THIS DEVICE WAS AT ERI ON (B)(6) 2019. THE PATIENT WAS BROUGHT IN WHERE A DATA DUMP WAS TAKEN FROM THE DEVICE AND IT CONFIRMED ERI. THE DEVICE REMAINS IMPLANTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8661329 ↗
• MalfunctionMar 29, 2019Battery Problem; Battery Problem

  DEVICE HAD 60 PERCENT REMAINING IN (B)(6) BUT READ ERI ON (B)(6) 2019. THE DEVICE REMAINS IMPLANTED, BUT A CHANGE OUT IS BEING SCHEDULED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8465351 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS ORIGINALLY SUBMITTED VIA ASR Q3 2016, HOWEVER BIOTRONIK DOES NOT PARTICIPATE IN ASR REPORTING ANY LONGER. SUBMITTING THE INITIAL REPORT NOW AS REQUESTED BY FDA. THIS SYSTEM WAS REMOVED DUE TO INFECTION. A NEW SYSTEM WAS IMPLANTED ON (B)(6) 2016.

  Patient problems: Unspecified Infection

  MAUDE report 7114406 ↗