SUREFIXRecalls & reported problems across all models

We found 3 models of SUREFIX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Jul 8, 2026 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SUREFIX problems

SUREFIX models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SUREFIX® 5072-45

  permanent pacemaker Electrode
  21 reports
• SUREFIX® 5072-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 reports
• SUREFIX® 5072-58

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 report

Recent SUREFIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AND THERE WAS A FAILED ATRIAL LEAD POSITION CHECK (ALPC). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748208 ↗
• MalfunctionMar 20, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE, RESULTING IN TERMINATION OF THE AT/AF DETECTED EVENT IN PROGRESS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649959 ↗
• MalfunctionJun 3, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129714 ↗
• MalfunctionMay 28, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096544 ↗
• MalfunctionSep 3, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SENSING INTEGRITY COUNTER (SIC). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128312 ↗
• InjurySep 3, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123204 ↗
• MalfunctionFeb 13, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693824 ↗
• MalfunctionNov 10, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING/ ATRIAL EVENTS FALLING IN BLANKING NOTED ON PRESENTING EGM. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109437 ↗
• MalfunctionOct 12, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918371 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE AND A PREVIOUSLY CAPPED ADAPTOR WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17610763 ↗
• MalfunctionAug 3, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING THE ATRIAL ARRHYTHMIA. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449095 ↗
• InjuryJul 19, 2023Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350636 ↗
• InjuryMay 26, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO PACING, OVERSENSING AND CROSSTALK. THE RV LEAD HAS A NOTED HISTORY OF T WAVE OVERSENSING AND WAS REPROGRAMMED WITH THE PATIENT THEN EXPERIENCING SYNCOPE. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 17008838 ↗
• InjuryMay 22, 2023Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE DUE TO INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAD HIGH THRESHOLDS AND THAT THE THRESHOLDS ROSE, LEADING TO INTERMITTENT CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 16974405 ↗
• MalfunctionMay 22, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASING FATIGUE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED SUSPECTED LOSS OF CAPTURE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 16972383 ↗

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