NA 5071-25 (UDI 00643169638624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169638624), received between Oct 19, 2018 and May 13, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE RA LEAD DISPLAYED NOISE, OVER SENSING AND DIMINISHED SENSING. ADDITIONALLY, BOTH RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS. BOTH THE RV LEADS AND RA LEAD WERE 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 25157751 ↗
• InjuryMay 13, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE RA LEAD DISPLAYED NOISE, OVER SENSING AND DIMINISHED SENSING. ADDITIONALLY, BOTH RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS. BOTH THE RV LEADS AND RA LEAD WERE 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 25157740 ↗
• MalfunctionMar 24, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A UNIPOLAR LOW IMPEDANCE WARNING. 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 24679343 ↗
• MalfunctionFeb 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PACING LEAD EXHIBITED AN ALERT. THE PACING 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 24278005 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT EXPERIENCE AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20630888 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO AN ONGOING INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17772944 ↗
• InjuryNov 1, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707397 ↗
• InjuryNov 19, 2021

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843685 ↗
• InjuryOct 23, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AT HIGH OUTPUT AND LOSS OF CAPTURE. THE RV LEAD WAS CUT, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10725068 ↗
• MalfunctionMay 29, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 10100857 ↗
• InjuryDec 18, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS SINCE IMPLANT. THE LEAD WAS CAPPED AND REP LACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488532 ↗
• InjuryJan 10, 2019Signal Artifact/Noise; Fracture; Under-Sensing; Capturing Problem; High Capture Threshold; Signal Artifact/Noise; Fracture; Under-Sensing; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS NOISE, INCREASED, FRACTURE AND HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEADS. THERE WAS ALSO UND ERSENSING ONE OF THE RV LEADS. THE LEADS WERE EXPLANTED AND REPLACED. DURING THE LEAD REPLACEMENT, THERE WAS INSULATION BREACH DISCOVERED ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD WAS REPAIRED AND 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 8237054 ↗
• MalfunctionOct 19, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLD MEASUREMENTS. 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 7985476 ↗