Attain® Performa™ 429888Recalls & reported problems

Summary

The FDA's MAUDE database contains 606 adverse event reports that list this exact device (DI 00643169002715), received between Aug 5, 2015 and Sep 23, 2026 — classified as 7 deaths, 459 injuries, 140 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (169 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 25 most recent of 606 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Capturing Problem

  It was reported that the Left Ventricular (LV) lead "thresholds "[were]" leading to increased battery drain" from the Cardiac Resynchronization Therapy Defibrillator (CRT-D). The lead was reprogrammed, and the lead and the device 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 50873457 ↗
• MalfunctionSep 17, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high capture thresholds. 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 50802038 ↗
• MalfunctionSep 10, 2026High Capture Threshold

  It was reported that that the Left Ventricular (LV) lead exhibited possible high thresholds. The LV 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 50705484 ↗
• MalfunctionSep 8, 2026High impedance

  It was reported that the lead exhibited high impedance and Magnetic Resonance Imaging (MRI) Surescan mode could not be programmed for the device as a result. 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 50664170 ↗
• InjuryAug 25, 2026High impedance

  It was reported that the Left Ventricular (LV) lead triggered multiple alerts for undefined high pacing impedance. The lead was reprogrammed and 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 50432614 ↗
• InjuryAug 20, 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. The patient was experiencing discomfort, redness, and swelling. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 50354392 ↗
• InjuryJun 26, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND POSSIBLE LOSS OF CAPTURE. THE PATIENT WAS EXPERIENCING SYNCOPE. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25643931 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT DEVELOPING ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Endocarditis

  MAUDE report 25230599 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25029576 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO CHRONIC SWELLING. THE PATIENT EXPERIENCED INDURATION AND GRANULOMA. THE SYSTEM WAS REPLACED WITH A SINGLE CHAMBER PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Granuloma; Hypersensitivity/Allergic reaction; Swelling/ Edema; Unspecified Skin and Subcutaneous Tissue Problem

  MAUDE report 24817486 ↗
• InjuryApr 8, 2026Fracture; Difficult to Remove; Material Integrity 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 A POCKET INFECTION. THERE WAS VEGETATION OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE PATIENT HAD A POSITIVE CULTURE FOR KLEBSIELLA PNEUMONIAE. DURING EXPLANT, THE LEFT VENTRICULAR (LV) LEAD FRACTURED DISTALLY BEFORE THE ENTIRE LEAD COULD BE FULLY REMOVED. MOST OF THE LV LEAD WAS REMOVED EXCEPT FOR THE TIP, WHICH REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24817278 ↗
• InjuryApr 7, 2026Failure to Capture

  IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT PROCEDURE, NO CAPTURE WAS IDENTIFIED ON THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS PROGRAMMED OFF AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808817 ↗
• InjuryMar 24, 2026Extracardiac stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY EXPERIENCED PHRENIC NERVE STIMULATION, REPROGRAMMING OF THE LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED BUT NO OTHER VECTORS WERE VIABLE. THERE WAS ALSO POSSIBLE HIGH THRESHOLD ON THE LV LEAD AND THE LEAD WAS REPROGRAMMED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24673813 ↗
• MalfunctionMar 5, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD PACING VECTORS THAT EXHIBITED UNDEFINED HIGH PACING IMPEDANCES. THE LV 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 24524791 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA INFECTION ORIGINATING AS AN INFECTED INGROWN TOE NAIL. VEGETATION WAS OBSERVED ON THE DEVICE LEADS. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Medical device site infection

  MAUDE report 24459090 ↗
• MalfunctionFeb 19, 2026Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS REPORTED BY A FAMILY MEMBER, THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS "NOT WORKING CORRECTLY". 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 24393264 ↗
• InjuryFeb 3, 2026High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND UNSTABLE CAPTURE THRESHOLDS. THE LEAD WAS 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 24250930 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO EROSION AND INFECTION WITH PURULENT DISCHARGE/PUS. IT WAS NOTED THAT DURING THE REMOVAL OF THE RIGHT ATRIAL (RA) LEAD, THE LEAD SNAPPED OFF IN THE BODY, SO THAT LEAD WAS PARTIALLY REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24202260 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SHORTNESS OF BREATH.  THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION, AND AN ECHOCARDIOGRAM WAS PERFORMED WHICH SHOWED MOBILE ECHOGENIC DENSITY OF THE RIGHT VENTRICULAR (RV) LEAD CONCERNING FOR THROMBUS OR VEGETATION. IT WAS NOTED THAT BLOOD CULTURES WERE NEGATIVE.  A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND REVIEWED VEGETATION ON THE RIGHT ATRIAL (RA) LEAD CONSISTENT WITH ENDOCARDITIS.  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMAINS IN USE.  THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Endocarditis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23967765 ↗
• MalfunctionDec 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE ON THE CURRENT ELECTROGRAMS (EGM). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Angina; Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926582 ↗
• MalfunctionDec 22, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POTENTIAL T-WAVE OVERSENSING (TWOS). THE LV AND RV 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 23872465 ↗
• MalfunctionDec 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN IMPEDANCE WARNING DUE TO UNDEFINED OUT OF RANGE (OOR) HIGH DEFIBRILLATION IMPEDANCE. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR UNDEFINED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. BOTH 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 23819011 ↗
• InjuryDec 10, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED UNACCEPTABLE CAPTURE THRESHOLDS. THE LEAD WAS CAPPED WITH NO REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766504 ↗
• InjuryNov 18, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS 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 23586725 ↗
• MalfunctionOct 31, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PULSATING FEELING AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SITE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE ON STORED EPISODES. THE CRT-D AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439817 ↗