NA 6996SQ41 (UDI 00721902183065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00721902183065), received between Feb 8, 2018 and Apr 3, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 16, 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.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24781784 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 22783486 ↗
• InjuryFeb 5, 2025Fracture; Impedance Problem; Fracture; Impedance Problem

  IT WAS REPORTED THAT THERE WAS RISING RIGHT VENTRICULAR (RV) DEFIBRILLATOR COIL IMPEDANCE AND A SUSPECTED FRACTURE WITH THE TRANSVENOUS RV LEAD. IN ADDITION, THERE WAS RISING SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE AND A SUSPECTED FRACTURE WITH THE RV SUBCUTANEOUS LEAD. THE LEADS WERE 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 21314639 ↗
• MalfunctionNov 7, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) COIL LEAD AND SUPERIOR VENA CAVA (SVC) COIL LEAD TRIGGERED ALERTS FOR HIGH OUT OF RANGE (OOR) IMPEDANCES AND A GRADUAL RISE IN BOTH IMPEDANCES WERE NOTED. THE LEADS 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 20631800 ↗
• InjuryJul 31, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS FURTHER REPORTED THAT THE SVC WAS PROGRAMMED OFF. THE LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425077 ↗
• InjuryDec 12, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD PULLED UP INTO THE POCKET. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960237 ↗
• MalfunctionDec 22, 2021High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS AN ALERT SUPERIOR VENA CAVA (SVC) LEAD FOR HIGH/UNDEFINED PACING IMPEDANCE. 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 13059765 ↗
• InjuryJul 13, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THERE WAS HIGH/UNDEFINED IMPEDANCES ON THE SUBCUTANEOUS HIGH VOLTAGE LEAD COIL. THE LEAD WAS SUSPECT OF A FRACTURE. THE SUBCUTANEOUS LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160051 ↗
• MalfunctionJan 27, 2021Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE EPICARDIAL PACING LEADS HAS LOW IMPEDANCE THAT HAS BEEN TRENDING DOWN AND TRIGGERED AN IMPEDANCE WARNING. THE LEADS 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 11237997 ↗
• MalfunctionSep 13, 2018Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE SUBCUTANEOUS COIL MEASURED HIGH OUT OF RANGE IMPEDANCE. AN X-RAY REVEAL ED THAT THE RV COIL HAD FRACTURED. THE RV COIL 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 7875348 ↗
• InjuryJul 18, 2018Fracture; High impedance; Impedance Problem; Fracture; High impedance

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED THE ALERT FOR HIGH/UNDEFINED SVC IMPEDANCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7698534 ↗
• MalfunctionApr 10, 2018Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) HIGH VOLTAGE LEADS DISPLAY ELEVATED IMPEDANCE MEASUREMENTS ON THE HIGH VOLTAGE COILS. FOLLOW-UP WAS COMPLETED AND NO REPROGRAMMING HAS BEEN COMPLETED AT THIS TIME. THE LEADS REMAIN 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 7417914 ↗
• InjuryFeb 8, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE. THE LEAD ALSO EXHIBITED SHORT VENTRICULAR INTERVALS. HIGH AND UNDEFINED IMPEDANCE WERE ALSO OBSERVED ON THE PACING AND RIGHT VENTRICULAR DEFIBRILLATION PORTIONS OF THE LEAD. HIGH AND UNDEFINED IMPEDANCE WERE ALSO NOTED ON THE SUBCUTANEOUS DEFIBRILLATION COIL LOCATED IN THE SUPERIOR VENA CAVA (SVC). DEFIBRILLATION THERAPIES WERE TURNED OFF AND THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7257730 ↗