Safio S 53 370945Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04035479113940), received between Apr 9, 2019 and Mar 9, 2022 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 106 MONTHS IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS AND OVERSENSING. A REVIEW OF DATA SHOWED THAT THIS FILE WAS INADVERTENTLY NOT ENTERED INTO THE SYSTEM AND IS THEREFORE RECORDED NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13704387 ↗
• MalfunctionOct 8, 2021Over-Sensing; Device Sensing Problem; Impedance Problem; Over-Sensing; Device Sensing Problem; Impedance Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 88 MONTHS, IT WAS REPORTED THAT OVERSENSING IN THE ATRIAL CHANNEL, SUDDENLY INCREASING PACING IMPEDANCE AND LOSS OF SENSING WERE DETECTED. THE LEAD IS NOW INACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12600707 ↗
• MalfunctionSep 8, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 54 MONTHS, OVERSENSING ON THE VENTRICULAR AND FARFIELD CHANNEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440350 ↗
• MalfunctionMay 24, 2021High impedance; High impedance

  AFTER AN IMPLANTATION PERIOD OF APPROX. 31 MONTHS, IT WAS REPORTED THAT AN INCREASING PACING IMPEDANCE WAS OBSERVED. THE LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869759 ↗
• MalfunctionMar 9, 2021Extracardiac stimulation; Ambient Noise Problem; Extracardiac stimulation; Ambient Noise Problem

  THIS LEAD WAS CAPPED AND REPLACED DUE TO BIPOLAR LEAD FAILURE, NOISE IN BIPOLAR PROGRAMMING, AND PECTORAL STIM IN UNIPOLAR PACING CONFIGURATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11449328 ↗
• MalfunctionJan 18, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT APPROX. 18 MONTHS AFTER THE IMPLANTATION LOSS OF CAPTURE WAS NOTED. THE PACEMAKER WAS EXPLANTED AND REPLACED, THE LEAD WAS CAPPED AND A NEW ONE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189481 ↗
• MalfunctionDec 7, 2020High impedance; High impedance

  IT WAS REPORTED, THAT AFTER APPROXIMATELY 67 MONTHS IMPEDANCE INCREASE OF THE RA-LEAD WAS DETECTED. A NEW RA-LEAD WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962559 ↗
• MalfunctionOct 13, 2020Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT APPROX. 48 MONTHS AFTER THE IMPLANTATION, DURING A FOLLOW-UP ERROR MESSAGES WERE SEEN FOR ATRIAL (SAFIO S 53) AND VENTRICULAR (SAFIO S 60) LEADS DUE TO AN IMPEDANCE ISSUE. IT WAS DECIDED TO EXPLANT THE LEADS AND PERFORM A NEW CRT-P IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10671624 ↗
• MalfunctionSep 1, 2020Failure to Capture; Failure to Capture

  AFTER AN IMPLANTATION PERIOD OF APPROX. 26 MONTHS, A LOSS OF CAPTURE ON THE ATRIAL CHANNEL WAS OBSERVED. THE LEADS WERE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10475729 ↗
• MalfunctionJul 22, 2020Break; Break

  IT WAS REPORTED THAT APPROX. 61 MONTHS AFTER IMPLANTATION, THE RV (LINOX SMART) AND RA (SAFIO) LEADS WERE EXPLANTED. INSULATION DAMAGE WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311861 ↗
• MalfunctionJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, A PATIENT WAS IMPLANTED WITH A NEW PACEMAKER. HOWEVER, DURING FOLLOW-UP BEFORE DISCHARGE ON (B)(6), IT WAS NOTED THAT THE RA AND RV LEADS WERE DISLODGED. ON MAY 28, THE DOCTOR PERFORMED LEAD RE-POSITIONING SURGERY FOR THE PATIENT, BUT THE LEADS DISLODGED AGAIN. THEN THE TWO LEADS WERE UNABLE TO BE FIXED. AT LAST, THE DOCTOR IMPLANTED OTHER 2 NEW LEADS FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171740 ↗
• MalfunctionJun 18, 2020Break; Fracture; Naturally Worn; Break; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE ATRIAL LEAD SHOWED INSULATION DAMAGE AND COIL FRACTURE DUE TO SUBCLAVIAN CRUSH SYNDROME APPROX. 29 MONTHS AFTER IMPLANTATION. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171407 ↗
• MalfunctionMay 28, 2020Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT APPROX. 72 MONTHS AFTER THE IMPLANTATION INTERMITTENT LOSS OF CAPTURE (ATRIAL) WAS NOTED. PATIENT RECEIVED A COMPLETE NEW SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099332 ↗
• MalfunctionApr 8, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT BOTH LEADS WERE EXPLANTED APPROX. 54 MONTHS AFTER IMPLANTATION. THE ATRIAL LEAD SHOWED OVERSENSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941668 ↗
• MalfunctionMar 11, 2020Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 67 MONTHS, OVERSENSING ON THE ATRIAL AS WELL AS ON THE VENTRICULAR CHANNEL WAS REPORTED. THE PATIENT WAS HOSPITALIZED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9820932 ↗
• MalfunctionJan 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS RA LEAD WAS EXPLANTED DUE TO DISLODGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9566813 ↗
• MalfunctionOct 28, 2019Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 43 MONTHS, OVERSENSING ON THE ATRIAL CHANNEL WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9248022 ↗
• MalfunctionOct 24, 2019Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT 59 MONTHS AFTER THE IMPLANT OF THIS SYSTEM OVERSENSING ON VENTRICULAR AND ATRIAL CHANNELS AND LOSS OF CAPTURE WERE NOTED. THE PACEMAKER AND THE LEADS REMAIN IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9235425 ↗
• MalfunctionOct 10, 2019Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT APPROX. 58 MONTHS AFTER THE IMPLANTATION THE LEAD WAS CAPPED DUE TO HIGH PACING IMPEDANCES, HIGH THRESHOLDS AND LOSS OF CAPTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9175405 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED THAT THE LEAD SHOWED AN INSULATION DAMAGE DURING THE EXTRACTION OF THE ASSOCIATED ICD LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141719 ↗
• MalfunctionAug 12, 2019Fracture; High Capture Threshold; Fracture; High Capture Threshold

  IT WAS REPORTED, THAT APPROXIMATELY 16 MONTHS AFTER IMPLANTATION, THE THRESHOLD VALUE OF THIS LEAD WAS INCREASED. AFTER FURTHER CHECKING BY X-RAY, IT WAS NOTED THAT THE LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8885996 ↗
• MalfunctionJul 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THE LEAD WAS IMPLANTED WHILE THE PATIENT WAS ON VACATION OUTSIDE OF THE US.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8803061 ↗
• MalfunctionApr 9, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  OUS MDR - THIS RA LEAD HAD NO CAPTURE AT MAX OUTPUT AND IMPEDANCES OF GREATER THAN 2500 OHMS. THIS LEAD WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Bradycardia

  MAUDE report 8496928 ↗