CapSureFix Novus MRI™ SureScan™ 407658 (UDI 00763000014650)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000014650), received between Feb 8, 2018 and Jul 29, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 29, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDER SENSING. 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 22643017 ↗
• InjuryApr 24, 2024Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE WITH UNDEFINED HIGH IMPEDANCE AND NO CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.;

  Patient problems: Bradycardia

  MAUDE report 19170877 ↗
• InjuryFeb 22, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD FRACTURE. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED HIGH PACING IMPEDANCE. THE RV 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 18756143 ↗
• InjuryJan 11, 2023Electrical /Electronic Property Problem; Fracture; Capturing Problem; Impedance Problem; Electrical /Electronic Property Problem; Fracture; Capturing Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED SPIKE IN IMPEDANCE AND POSSIBLE FRACTURE. THE RV LEAD WAS REPROGRAMMED, CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136971 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED BACTEREMIA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 14513103 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis

  MAUDE report 11639807 ↗
• MalfunctionFeb 16, 2021Break; High impedance; Impedance Problem; Break; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY INCREASING AND HIGH, PLATEAUED IMPEDANCE, SUGGESTING POSSIBLE CALCIFICATION. THE RV LEAD REMAINS IN USE. THE PHYSICIAN WILL MONITOR IMPEDANCE GOING FORWARD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334324 ↗
• InjuryApr 2, 2020Adverse 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 IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9915270 ↗
• InjuryFeb 13, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) LEAD IN UNIPOLAR CONFIGURATION. THE DEVICE WAS INTERROGATED AND THE LEAD WAS REPROGRAMMED TO BIPOLAR SENSING. 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 8337016 ↗
• MalfunctionNov 6, 2018Electrical /Electronic Property Problem; High impedance; Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A POLARITY SWITCH AND HIGH BIPOLAR LEAD IMPEDANCE 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 8043557 ↗
• InjuryOct 16, 2018Adverse 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 VEGETATIVE GROWTH ON THE LEADS. THE DEVICE SYSTEM WILL BE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7970401 ↗
• MalfunctionJun 26, 2018Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION ABLATION TREATMENT. BIPOLAR IMPEDANCE WARNINGS WERE RECORDED ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE RIGHT ATRIAL (RA) LEAD FOR LEAD IMPEDANCE. LOW IMPEDANCE WERE NOTED. 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 7639704 ↗
• InjuryApr 26, 2018Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST SYSTEM IMPLANT, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE WITH CARDIAC ARREST ON TELEMETRY. THE PATIENT HAD INJURIES TO HIS FACE AS A RESULT. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS LATER EVALUATED AND THE CAPTURE THRESHOLD AND IMPEDANCE WERE WITHIN NORMAL LIMITS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE THAT COULD NOT BE REPLICATED. THE PATIENT WAS EVALUATED AGAIN, AND THE RV LEAD CHECKED THROUGH THE DEVICE AND THE ANALYZER AND APPEARED TO BE FUNCTIONING NORMALLY. THE PHYSICIAN SUSPECTED A MICRO-FRACTURE OF THE RV LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER OF THE SAME LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Fall; Syncope

  MAUDE report 7464928 ↗
• MalfunctionApr 10, 2018Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD HELIX WAS TAKEN OUT OF THE PACKAGE AND EXERCISED PRIOR TO BEING PLACED IN THE BODY. ONCE PLACED AND BEFORE THE HELIX WAS EXTENDED, THE SIGNAL OBTAINED LOOKED NON-PHYSIOLOGIC AND "NOISY". OCCASIONAL DEFLECTIONS WOULD APPEAR AMIDST THE NOISY BASELINE AND SEEMED TO LINE UP WITH SURFACE QRS COMPLEXES. RECOGNIZING THAT THE HELIX WAS STILL RETRACTED, AND THAT THE ANATOMICAL LOCATION WAS DESIRABLE, THE PHYSICIAN EXTENDED THE HELIX IN THE USUAL FASHION TO AFFIX IT TO THE CARDIAC TISSUE. AT THIS POINT, THE NOISY BASELINE WAS GONE, AND CLEAR RV ELECTROGRAMS WERE NOTED. DESIRING LARGER R-WAVES, THE PHYSICIAN RETRACTED THE HELIX ONCE AGAIN AND THEN PLACED IT ON THE RV SEPTUM WHERE R-WAVES WERE LARGER. THE HELIX WAS ONCE AGAIN DEPLOYED FOR THE FINAL TIME AND SENSING/IMPEDANCE/THRESHOLDS REMAINED STABLE THROUGHOUT THE CASE. THE LEAD WAS LEFT IN THE FINAL POSITION 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 7417835 ↗
• InjuryFeb 8, 2018Break; Break

  IT WAS REPORTED THE TEMPORARY PACING LEAD "BROKE OFF". THE LEAD WAS REMOVED AND A PERMANENT SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256430 ↗