WiSE CRT System 4100Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00859244007005), received between Jun 12, 2025 and Jun 30, 2026 — classified as 2 deaths, 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Power Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 30, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT ELECTRODE TRACKING WAS OCCASIONALLY INTERMITTENT AND COULD NOT BE MAINTAINED IN ANY LOCATION. DURING SUBSEQUENT EVALUATION, THE TRANSMITTER WAS IDENTIFIED AS FLIPPED. THE INITIAL IMPLANT WAS PERFORMED ON (B)(6) 2026, AND WAS TECHNICALLY CHALLENGING DUE TO TISSUE DEPTH AND PATIENT BODY HABITUS (PATIENT WEIGHT APPROXIMATELY 450 LBS). NO ELECTRODE TRACKING ISSUES WERE NOTED DURING THIS INITIAL PROCEDURE. A REPEAT ELECTRODE IMPLANT WAS PERFORMED ON (B)(6) 2026, AT WHICH TIME THE FLIPPED TRANSMITTER WAS IDENTIFIED. THE TRANSMITTER POCKET AND PLACEMENT WERE NOT REVISED DURING THIS PROCEDURE; THEREFORE, SUTURE-RELATED ISSUES COULD NOT BE ASSESSED. PER PHYSICIAN DISCUSSION, POTENTIAL DEVICE MANIPULATION BY THE PATIENT WAS CONSIDERED. THE PATIENT REPORTED THAT AT AN UNSPECIFIED DATE, HE BENT OVER AND FELT A "POP." A TRANSMITTER REVISION PROCEDURE IS SCHEDULED FOR (B)(6) 2026.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25669717 ↗
• MalfunctionMay 27, 2026Human-Device Interface Problem

  IT WAS REPORTED " THE PATIENT'S CONDITION HAS RECENTLY WORSENED. HE IS RETAINING FLUID AND BECOMES VERY SHORT OF BREATH WHEN WALKING". ADDITIONAL INFORMATION STATES "IT IS UNKNOWN IF THE PHYSICIAN BELIEVED THAT THE PATIENT'S WORSENING CONDITION OR FLUID RETENTION WAS RELATED TO REDUCED BIV PACING OR WISE PERFORMANCE. WHEN THE PATIENT HAD TROUBLE IN PREVIOUS POSITIONS MINIMAL TRACKING WAS OBSERVED IN ALL POSTURES. THERE IS NO WAY TO DETERMINE IF THERE WERE ANY REPORTS OF POSTURE-DEPENDENT LOSS OF THERAPY AT HOME WITHOUT HAVING AN M5100 IN THE HOME TO OBSERVE LOC. THE PATIENT DID NOT REPORT SYMPTOMS THAT CORRELATED WITH POSITIONAL CHANGES OR LOSS OF PACING. THE REDUCED BIV PACING WAS PRESUMABLY RELATED TO THE PLEURAL EFFUSION. THE WISE SYSTEM WAS TRACKING AT 71% UPON INITIAL INTERROGATION. THE PHYSICIAN DID NOT RECOMMEND ANY INTERVENTION OR SYSTEM REVISION RELATED TO SUSPECTED WISE PERFORMANCE. THERE WERE NO CONCERNS REGARDING TRANSMITTER POSITION, ACOUSTIC WINDOW QUALITY, OR ELECTRODE LOCATION CONTRIBUTING TO REDUCED THERAPY DELIVERY".

  Patient problems: Unspecified Heart Problem

  MAUDE report 25302142 ↗
• MalfunctionMay 18, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT " THE PATIENT'S SYMPTOMS HAD NOT IMPROVED AND A RECENT CHEST X-RAY REPORTEDLY DEMONSTRATED SIGNIFICANT ROTATION OF THE IMPLANTED MODEL 4100 TRANSMITTER, DESCRIBED AS POINTING DOWNWARD. THE ROTATED TRANSMITTER POSITION REPORTEDLY RESULTED IN MINIMAL TRACKING AT MAXIMUM OUTPUT SETTINGS. TROUBLESHOOTING AND OPTIMIZATION WERE PERFORMED IN ACCORDANCE WITH THE WISE FOLLOW-UP BEST PRACTICE FLOWCHART. ADJUSTMENT OF THE GSC TO THE TOP AND BOTTOM OF THE SEARCH FIELD RESULTED IN INTERMITTENT TRACKING AND INTERMITTENT BIVENTRICULAR (BIV) PACING ONLY AT MAXIMUM OUTPUT AND PULSE WIDTH SETTINGS AND ONLY WHILE THE PATIENT WAS IN A LEANED-BACK SITTING POSITION". ADDITIONAL INFORMATION RECEIVED STATES "IT IS UNKNOWN WHEN THE ROTATED TRANSMITTER WAS FIRST IDENTIFIED, BUT THERE IS X-RAY TO CONFIRM. THERE WAS AN ATTEMPT MADE TO FEEL THE TRANSMITTER POCKET, BUT THE PATIENT HAD EXCESSIVE TISSUE MAKING IT DIFFICULT TO ASSESS TRANSMITTER POSITION. THE LEANED-BACK SITTING POSITION WAS THE ONLY POSITION WHERE THE BIV WAS ACHIEVED AT MAX OUTPUT. THE PHYSICIAN TALKED TO THE PATIENT AND THEY BOTH AGREED TO HOLD OFF ON ANY FURTHER ACTION AND CONTINUE TO ASSESS THE SITUATION. THE PATIENT IS S

  Patient problems: Unspecified Heart Problem

  MAUDE report 25202486 ↗
• InjuryFeb 25, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, THE CLINICAL SITE REPORTED THAT A PATIENT EXPERIENCED ABNORMAL HEART SENSATIONS. NO ADDITIONAL DETAILS REGARDING SEVERITY, DURATION, OR DEVICE PERFORMANCE WERE PROVIDED AT THE TIME OF INITIAL NOTIFICATION. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24448548 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IN THE WISE-UP REGISTRY STUDY EXPERIENCED SIGNIFICANT LEFT CHEST WALL PAIN (8/10) BEGINNING ON THE EVENING OF THE PROCEDURE AND PERSISTING OVERNIGHT. PHYSICAL EXAMINATION IDENTIFIED LOCALIZED SWELLING AND TENDERNESS CONSISTENT WITH A HEMATOMA, WITHOUT ACTIVE BLEEDING. HEMOGLOBIN REMAINED STABLE, WITH MILD LEUKOCYTOSIS CONSIDERED REACTIVE TO THE RECENT PROCEDURE. CHEST X-RAY SHOWED NO PNEUMOTHORAX OR OTHER ACUTE COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Unspecified Heart Problem

  MAUDE report 24254536 ↗
• MalfunctionJan 27, 2026Power Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, COMMUNICATION WITH THE WISE CRT SYSTEM COULD NOT BE ESTABLISHED DESPITE BEST-PRACTICE TROUBLESHOOTING. THE CO-IMPLANTABLE CARDIAC DEVICE WAS FUNCTIONING NORMALLY WITH RIGHT VENTRICULAR PACING ONLY. ECG ASSESSMENT FOLLOWING ADJUSTMENT OF THE RIGHT VENTRICULAR PULSE WIDTH SHOWED NO LEFT VENTRICULAR PACING CONTRIBUTION, INDICATING A LACK OF WISE SYSTEM FUNCTIONALITY. THIS FINDING WAS UNEXPECTED GIVEN A WISE BATTERY REPLACEMENT IN (B)(6) 2025. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24194719 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST SUBCUTANEOUS IMPLANTATION OF THE WISE CRT SYSTEM PULSE GENERATOR, THE PATIENT DEVELOPED A HEMATOMA. THERE IS NO EVIDENCE OF ACTIVE BLEEDING. THIS EVENT WAS ALSO RESOLVED WITHOUT ANY PATIENT SEQUELAE.

  Patient problems: Hematoma

  MAUDE report 23930632 ↗
• MalfunctionDec 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A WISE CRT SYSTEM PATIENT WAS EVALUATED EARLIER THAN SCHEDULED DUE TO AN ERRATIC BATTERY CURVE, MOST LIKELY RELATED TO A FEED THROUGH ISSUE. DESPITE THIS FINDING, OVERALL SYSTEM PERFORMANCE REMAINED STABLE, WITH CHRONICALLY ELEVATED RV THRESHOLDS AND APPROXIMATELY 82% BIV/TRACKING. THE PATIENT WILL BE REVIEWED AGAIN IN ONE MONTH TO REASSESS ONGOING SYSTEM FUNCTIONALITY AND TO PLAN POTENTIAL SYSTEM REPLACEMENT. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23858107 ↗
• DeathDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED ON 12/19/2025 INDICATED THAT THE PATIENT HAD PASSED AWAY. ACCORDING TO THE CLINICAL SITE, THE DEATH WAS CLASSIFIED AS NON-CARDIAC, WITH THE PRIMARY CAUSE OF DEATH BEING RESPIRATORY FAILURE. THERE WAS NO RELATIONSHIP IDENTIFIED BETWEEN THE REPORTED DEATH AND THE PROCEDURE OR THE WISE DEVICES.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23846291 ↗
• DeathNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO PREVIOUSLY UNDERWENT A BATTERY AND A TRANSMITTER (B&T) REPLACEMENT ON (B)(6) 2025, EXPERIENCED A FATAL VENTRICULAR FIBRILLATION (VF) EVENT. POST-OPERATIVELY, A LOCALIZED HEMATOMA WAS NOTED AT THE BATTERY POCKET; HOWEVER, IT REMAINED CONTROLLED AND WAS IMPROVING. A FEW DAYS AFTER THE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN EPISODE OF VF UNRELATED TO THE WISE CRT SYSTEM AND WAS TREATED WITH SHOCKS FROM THE CO-IMPLANTABLE ICD. DURING HOSPITALIZATION, LABORATORY VALUES SHOWED LOW POTASSIUM, AND CORRECTIVE TREATMENT WAS ADMINISTERED. ON (B)(6) 2025, THE PATIENT COLLAPSED WHILE ATTEMPTING TO USE THE BATHROOM AND WAS FOUND IN VF ARREST. MULTIPLE ICD SHOCKS WERE DELIVERED, BUT THE PATIENT REMAINED IN REFRACTORY VF. RESUSCITATION EFFORTS WERE UNSUCCESSFUL, AND THE PATIENT PASSED AWAY. AT THIS TIME, THERE IS NO INDICATION OF A MALFUNCTION OR PERFORMANCE ISSUE INVOLVING THE WISE CRT BATTERY OR TRANSMITTER THAT CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 23528205 ↗
• MalfunctionOct 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A 77-YEAR-OLD MALE WITH A WISE CRT SYSTEM (IMPLANTED ON (B)(6) 2020, SOLVE STUDY) UNDERWENT TRANSMITTER AND BATTERY REPLACEMENT DUE TO PRIOR TRANSMITTER FAILURES (2021, 2022) AND LOSS OF DEVICE INTERROGATION SINCE 2022. THE PROCEDURE WAS UNCOMPLICATED, WITH CONSISTENT BIV PACING CONFIRMED POST-OP. FOLLOW-UP AND WOUND CARE ARE ONGOING. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23229148 ↗
• MalfunctionSep 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT UNDERWENT A BATTERY AND TRANSMITTER REPLACEMENT ON (B)(6) 2025 DUE TO THE TRANSMITTER BEING AFFECTED BY THE FEED THROUGH ISSUE. PREVIOUSLY, IN (B)(6) 2023, THE PATIENT HAD A BATTERY REPLACEMENT DUE TO AN IRREGULAR BATTERY CURVE AND PREMATURE DEPLETION. DURING THE MOST RECENT FOLLOW-UP IN (B)(6) 2024, CONNECTION TO THE WISE CRT SYSTEM COULD NOT BE ESTABLISHED. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22986872 ↗
• MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT WAS SEEN FOR A DEVICE FOLLOW-UP ON (B)(6) 2025, AFTER HAVING A BATTERY AND TRANSMITTER REPLACEMENT. DURING THE VISIT, RIGHT VENTRICULAR (RV) PACING DETECTION IMPROVED AFTER REPROGRAMMING AND SYNCING WITH THE CO-IMPLANT PULSE WIDTH. HOWEVER, THE PATIENT WAS NOT RECEIVING THE FULL BENEFIT OF BIVENTRICULAR (BIV) PACING, WHICH WAS ESTIMATED TO BE EFFECTIVE LESS THAN 40% OF THE TIME. BIV CAPTURE AND TRACKING WERE NOTICEABLY AFFECTED BY THE PATIENT'S BREATHING, WITH BETTER RESULTS DURING DEEP EXHALATION OR WHEN LYING ON THE LEFT SIDE. DESPITE THESE ISSUES, THE PATIENT HAD NO SYMPTOMS, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22974281 ↗
• MalfunctionAug 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  DURING A ROUTINE 4-YEAR FOLLOW-UP AT (B)(6), FLUCTUATIONS IN BATTERY VOLTAGE WERE OBSERVED ON THE BATTERY PERFORMANCE CURVE OF THE PATIENT'S WISE CRT (CARDIAC RESYNCHRONIZATION THERAPY) SYSTEM. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE CLINICAL OUTCOMES OR SEQUELAE ATTRIBUTED TO THE DEVICE OR THE OBSERVED BATTERY VOLTAGE FLUCTUATIONS.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22745622 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DURING THE FIRST FOLLOW UP AFTER IMPLANTATION, THE PATIENT REPORTED SYMPTOMS SUGGESTIVE OF AN INFECTION NEAR THE TRANSMITTER IMPLANTATION SITE. ON EXAMINATION, THE IMPLANTING PHYSICIAN OBSERVED FINDINGS CONSISTENT WITH A FUNGAL INFECTION AT THE WOUND SITE. AN ANTIFUNGAL CREAM WAS PRESCRIBED FOR TREATMENT. A REPORT SUMMARIZING THE FINDINGS AND TREATMENT PLAN WILL BE SENT TO THE PATIENT'S PRIMARY CARE PHYSICIAN AND CARDIOLOGIST TO SUPPORT COORDINATED CARE AND MONITOR THE PATIENT'S RESPONSE TO THERAPY. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

  Patient problems: Wound Infection

  MAUDE report 22487696 ↗
• MalfunctionJun 25, 2025Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  DURING AN IN-CLINIC FOLLOW-UP VISIT, THE BATTERY CURVE APPEARED ERRATIC AND NOISY. NO INTERVENTION WAS PERFORMED AT THIS TIME AND THE PATIENT WILL CONTINUED TO BE MONITORED. NO ADVERSE SEQUELAE WAS REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22333530 ↗
• MalfunctionJun 12, 2025Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

  DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE BATTERY CURVE OF THE PATIENT'S WISE CRT SYSTEM SHOWED SOME NOISE. DESPITE THIS, THE DEVICE WAS FUNCTIONING NORMALLY. THE BATTERY VOLTAGE MEASURED 2.68V, WITH APPROXIMATELY 10% CAPACITY REMAINING. THE PATIENT HAS A TRANSMITTER IMPACTED BY THE KRYOFLEX FEEDTHROUGH ISSUE AND IS MONITORED EVERY THREE MONTHS TO EVALUATE DEVICE PERFORMANCE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22196627 ↗
• MalfunctionJun 12, 2025Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  AN ELDERLY PATIENT ATTENDED A FOLLOW-UP VISIT ON (B)(6) 2025 AT (B)(6) HOSPITAL. DURING THE VISIT, COMMUNICATION WITH THE WISE CRT SYSTEM COULD NOT BE ESTABLISHED DESPITE ADHERENCE TO BEST PRACTICE PROTOCOLS. ECGS CONFIRMED RIGHT VENTRICULAR PACING ONLY, EVEN AFTER PULSE WIDTH ADJUSTMENTS. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22196134 ↗