SUREFIX® 5072-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885074311869), received between Apr 6, 2017 and Jul 8, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 19, 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 16202652 ↗
• InjuryDec 20, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND HIGH IMPEDANCE. 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 13042127 ↗
• MalfunctionDec 22, 2020Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING AND HISTORICALLY LOW MEASURED P WAVES. 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 11055481 ↗
• MalfunctionSep 24, 2020Under-Sensing; Under-Sensing

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10578893 ↗
• MalfunctionApr 3, 2020Under-Sensing; Under-Sensing

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

  Patient problems: Atrial Flutter

  MAUDE report 9919675 ↗
• MalfunctionFeb 8, 2019High impedance; Capturing Problem; Impedance Problem; High impedance; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE HAD RISEN TO HIGH LEVEL. IT WAS NOTED THAT THE RA LEAD EXPERIENCED RISING THRESHOLDS. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323350 ↗
• MalfunctionOct 30, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING OF THE PATIENT'S ARRHYTHMIA, EVEN THOUGH IT WAS STILL DETECTING THE ARRHYTHMIA, IT WAS SUSPENDED IN MODE SWITCH AND NOT COUNTING ALL THE BEATS AND THE ATRIAL RATE APPEARED TO BE TWICE THE RATE THAT WAS BEING DETECTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020522 ↗
• InjuryAug 9, 2017Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD NOISE. THE LEADS WERE BOTH EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783141 ↗
• MalfunctionAug 9, 2017Over-Sensing; Over-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781816 ↗
• InjuryApr 6, 2017Failure to Capture; Under-Sensing; High Capture Threshold; Failure to Capture; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING, NOISE WITH HIGH RATE NON SUSTAINED EPISODES. THE LEAD WAS EXPLANTED AND REPLACED. AS WELL, THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXPERIENCED HIGH THRESHOLDS, NON CAPTURE, AND COMPLETE UNDERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6470660 ↗