SPRINT QUATTRO® 6944-58 (UDI 00643169440852)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169440852), received between Oct 6, 2017 and Jun 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Capturing Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19601239 ↗
• InjuryMay 15, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD WITH OVER ONE-HUNDRED SHORT V-V INTERVALS AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND NOISE WAS NOTED. IT WAS FURTHER REPORTED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE (EMI)/NOISE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A LOOSE SET SCREW ISSUE WAS SUSPECTED. THE RV LEAD AND ICD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322735 ↗
• InjuryApr 12, 2022Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD RISING THRESHOLDS AND HIGH/UNDEFINED PACING IMPEDANCE. THE LEAD IS SUSPECTED TO BE FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084059 ↗
• InjuryOct 6, 2017Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A MICRODISLODGEMENT AND HIGH THRESHOLDS. THE LEAD WAS REVISED, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND THE REST OF 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 6924876 ↗