CapSureFix Novus MRI™ SureScan™ 407665Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169708211), received between Dec 2, 2021 and Apr 1, 2026 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED POST OPERATIVELY FOLLOWING THE IMPLANT OF NEW IMPLANTABLE PULSE GENERATOR (IPG). THE RA 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 24755116 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA INFECTION. THE PHYSICIAN BELIEVED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS NOT THE SOURCE OF INFECTION; HOWEVER, THE CRT-P SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 23834775 ↗
• MalfunctionDec 16, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE DETECTION. 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 23815840 ↗
• InjuryNov 4, 2025Over-Sensing; Under-Sensing; Decreased Sensitivity; Impedance Problem; Over-Sensing; Under-Sensing; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DIMINISHED R WAVES AND R WAVE UNDERSENSING WAS NOTED ON THE PRESENTING ELECTROGRAMS (EGM) WITH A HIGH NUMBER OF SHORT V-V INTERVALS OBSERVED. FALLING IMPEDANCE WAS ALSO OBSERVED. THE RV SENSITIVITY WAS RE-PROGRAMMED AND OVERSENSING WAS REPRODUCIBLE WITH ISOMETRICS. 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 23463408 ↗
• InjuryMar 25, 2025Signal Artifact/Noise; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT COLLAPSED AND WAS IN A NECK BRACE. THE PATIENT EXPERIENCED ASYSTOLE, BRADYCARDIA DIZZINESS AND SYNCOPE. AN INTERROGATION REPORT INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE AND A POLARITY SWITCH AS TRIGGERED. IN ADDITION, THE RV LEAD EXHIBITED OVERSENSING WITH POSSIBLE NOISE ON STORED ELECTROGRAMS (EGM) AND HAD A HIGH NUMBER OF SHORT V-V INTERVALS. A LOW VOLTAGE LEAD FRACTURE WAS CONFIRMED. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Bradycardia; Dizziness; Syncope/Fainting

  MAUDE report 21686076 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO EROSION. THE CRT-P WAS USED AS AN EXTERNAL PACEMAKER ATTACHED TO A TEMPORARY LEAD UNTIL A NEW SYSTEM WAS IMPLANTED THE NEXT DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 21610519 ↗
• MalfunctionOct 22, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE OCCASIONAL UNDERSENSING ON STORED EPISODES. 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 20504708 ↗
• MalfunctionAug 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INCORRECT SERIAL NUMBER FOR THE RIGHT VENTRICULAR (RV) LEAD WAS REGISTERED TO THE PATIENT. IT WAS ALSO REPORTED THAT THE RV LEAD WAS ATTEMPTED NOT USED AND SCRAPPED FOR UNKNOWN REASON. THE PATIENT REGISTRATION HAS BEEN UPDATED WITH THE CORRECT INFORMATION AND AN UPDATED PATIENT IDENTIFICATION CARD HAS BEEN SENT TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062112 ↗
• InjuryJul 25, 2024Pacing Problem; Capturing Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Pacing Problem; Capturing Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT ONE WEEK POST IMPLANT THE PATIENT EXPERIENCED ABDOMINAL / EPIGASTRIC PAIN WITH EMESIS. AN ODD PACED BEAT WAS OBSERVED BY EMERGENCY MEDICAL SERVICES. AN INTERROGATION REPORTED INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING THRESHOLDS AND FALLING IMPEDANCE SINCE IMPLANT AND THE RV HAD HIGH THRESHOLDS. THE PATIENT EXPERIENCED A RV CARDIAC PERFORATION CAUSING A PERICARDIAL EFFUSION THAT REQUIRED TO HAVE A DRAIN INSTALLED. THE RV LEAD WAS REMOVED AND REPLACED AND THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abdominal Pain; Cardiac Perforation; Chest Pain; Pericardial Effusion; Vomiting

  MAUDE report 19824778 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ATTEMPTED UPGRADE, BUT THE PATIENT BECAME COMBATIVE AND REQUIRED MULTIPLE PEOPLE TO HOLD HIM DOWN, SO THE POCKET WAS CLOSED. THE UPGRADE PROCEDURE WAS COMPLETED THE FOLLOWING DAY. APPROXIMATELY A MONTH LATER, THE PATIENT EXPERIENCED AN INFECTION, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. IT WAS ASSUMED THE CAUSE OF THE INFECTION WAS DURING THE INITIAL ATTEMPTED UPGRADE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19568673 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE INFECTION OCCURRED PRIOR TO THE IMPLANT AND THE PACING LEAD WAS NOT PART OF THE INFECTION AND WAS ONLY USED A BRIDGE TO THE PERMANENT LEADLESS IPG.

  Patient problems: Unspecified Infection

  MAUDE report 18502170 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY ONE WEEK POST IMPLANT THAT THE PATIENT DEVELOPED POCKET INFECTION WITH VISIBLE REDNESS AND PUS AT THE SITE OF INCISION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Discomfort; Erythema; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 17995699 ↗
• MalfunctionSep 21, 2023Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE ON THE CURRENT ELECTROGRAMS (EGM) AND UNDERSENSING. 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 17787075 ↗
• MalfunctionAug 4, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED POST-OPERATIVELY THAT UNDER-SENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD ALSO EXHIBITED A LEAD POSITION CHECK FAILURE. UNDER-SENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. 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 17457053 ↗
• InjuryJun 21, 2023Failure to Capture; Under-Sensing; Decreased Sensitivity; High Capture Threshold; Failure to Capture; Under-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED APPROXIMATELY THREE WEEKS POST IMPLANT OF A RIGHT VENTRICULAR (RV) LEAD THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED LOSS OF CAPTURE, CHRONIC HIGH THRESHOLDS, NO T-WAVES ON SOME PACED BEATS AND LOW R WAVES. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 17169161 ↗
• MalfunctionFeb 13, 2023Capturing Problem; Capturing Problem

  IT WAS FURTHER REPORTED THAT THE CPR WAS PERFORMED DUE TO RESPIRATORY ARREST AND NOT DUE TO A DEVICE MALFUNCTION. IT WAS ALSO NOTED THAT THE LEAD IMPEDANCE WARNING THAT WAS TRIGGERED ON THE RV LEAD WAS DUE TO VARYING IMPEDANCE THAT IS NOW STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363781 ↗
• InjuryMar 10, 2022Signal Artifact/Noise; Break; Over-Sensing; Signal Artifact/Noise; Break; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, POSITION CHECK FAILURE AND POSSIBLE INSULATION DAMAGE UNDERNEATH THE SUTURE SLEEVE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE INSULATION DAMAGE UNDERNEATH THE SUTURE SLEEVE, NOISE AND SHORT V-V INTERVALS. BOTH 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 13719935 ↗
• MalfunctionDec 2, 2021Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND FALLING IMPEDANCE. IT WAS NOTED THE PATIENT EXPERIENCED CHEST PAIN. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 12914888 ↗