WiSE CRT System 3100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00859244007029), received between Sep 5, 2025 and Sep 24, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Human-Device Interface Problem

  Patient problems: Hematoma; Unspecified Heart Problem

  MAUDE report 50890691 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON MAY 19, 2026, PROVIDED FURTHER DETAILS REGARDING THE REPORTED HEMATOMA AND PATIENT SYMPTOMS. IT WAS REPORTED THAT THE PATIENT WAS EVALUATED IN THE OFFICE ON (B)(6) 2026, FOR A HEMATOMA LOCATED NEAR THE DEVICE POCKET, DESCRIBED AS MODERATE IN SIZE. IT IS UNKNOWN WHETHER THE HEMATOMA WAS PRESENT IMMEDIATELY FOLLOWING THE PROCEDURE OR DEVELOPED SUBSEQUENTLY. INFORMATION REGARDING RESOLUTION STATUS, NEED FOR MEDICAL OR SURGICAL INTERVENTION, USE OF ANTICOAGULANT OR ANTIPLATELET MEDICATIONS, AND THE PRESENCE OF INFECTION, SKIN BREAKDOWN, ACTIVE BLEEDING, OR SWELLING WAS NOT AVAILABLE. THE PATIENT REPORTED DISCOMFORT ASSOCIATED WITH THE HEMATOMA; HOWEVER, SEVERITY WAS NOT SPECIFIED. ADDITIONALLY, SORENESS WAS REPORTED AT THE TRANSMITTER INCISION SITE AND WAS DESCRIBED AS MILD TO MODERATE. THE SORENESS DID NOT IMPACT THE PATIENT'S ABILITY TO PERFORM DAILY ACTIVITIES. IT IS UNKNOWN WHETHER THE SORENESS IS IMPROVING, STABLE, OR WORSENING, AND NO INFORMATION WAS PROVIDED REGARDING ANY RECOMMENDED OR PRESCRIBED TREATMENT.

  Patient problems: Hematoma

  MAUDE report 25118828 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON APRIL 17, 2026, THAT A PATIENT UNDERWENT EXPLANTATION OF THE WISE CRT SYSTEM BATTERY (MODEL 3100, S/N (B)(6)) AND TRANSMITTER (MODEL 4100, S/N (B)(6)) DUE TO POCKET EROSION WITH LOCAL SIGNS OF INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS, AND THE PATIENT WAS DISCHARGED. AT THE TIME OF EXPLANT, A SKIN DEFECT APPROXIMATELY THE SIZE OF A ONE-EURO COIN WAS OBSERVED OVER THE BATTERY POCKET, WITH THE DEVICE VISIBLE EXTERNALLY. THE EROSION WAS LOCALIZED TO THE BATTERY POCKET. MILD REDNESS WAS REPORTED BEGINNING APPROXIMATELY 3-4 DAYS PRIOR TO THE PROCEDURE. INFECTION WAS NOT MICROBIOLOGICALLY CONFIRMED. THE PATIENT WAS TREATED WITH ANTIBIOTICS (PIPERACILLIN/TAZOBACTAM AND CLINDAMYCIN) PRIOR TO EXPLANT. NO COMORBIDITIES OR RISK FACTORS WERE REPORTED. THE MOST RECENT BATTERY REPLACEMENT OCCURRED IN (B)(6) 2025, AND THE SURGICAL SITE WAS REPORTED AS FULLY HEALED AT THE LAST FOLLOW-UP IN (B)(6) 2026, WITH NO EARLY SIGNS OF EROSION OR INFECTION. A SCHEDULED FOLLOW-UP ON (B)(6) 2026, WAS MISSED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pocket Erosion

  MAUDE report 24948047 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING A POST-IMPLANT FOLLOW-UP EVALUATION, THE PATIENT STATED THAT SHE DEVELOPED A HEMATOMA WITH FLUID ACCUMULATION AT THE BATTERY INCISION SITE FOLLOWING THE PROCEDURE. THE CLINIC NURSE EXAMINED THE SITE AND CONFIRMED IT WAS SOFT WITH NO SIGNS OF INFECTION, AND THE CLINICAL TEAM ELECTED TO MONITOR THE AREA WHILE ALLOWING THE FLUID TO DISSIPATE NATURALLY. NO DIAGNOSTIC TESTING OR MEDICATION CHANGES WERE REPORTED, AND THERE WAS NO EVIDENCE OF INFECTION AT EITHER INCISION SITE OR BLOOD LOSS. THE AREA HAD REPORTEDLY SHIFTED TOWARD THE PATIENT'S BACK AND WAS APPROXIMATELY THE SIZE OF A SOFTBALL. THE EBR REPRESENTATIVE REPORTED THAT THE WISE CRT SYSTEM WAS FUNCTIONING AS INTENDED; HOWEVER, ELEVATED CAPTURE THRESHOLDS WERE OBSERVED COMPARED TO IMPLANT VALUES. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP EVALUATION IN MAY TO REASSESS SYSTEM PERFORMANCE. IT WAS NOTED THAT THRESHOLDS MAY DECREASE ONCE THE POST-OPERATIVE FLUID RESOLVES, WHICH MAY IMPROVE PROJECTED BATTERY LONGEVITY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 24586090 ↗
• InjuryFeb 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT WENT TO THE EMERGENCY ROOM THE WEEK BEFORE DUE TO AN INFECTION AT THE BATTERY POCKET SITE. ADDITIONAL INFORMATION INDICATED SWELLING AND REDNESS AT THE BATTERY POCKET SITE. WHILE THE PATIENT IS UNDERGOING ANTIBIOTIC TREATMENT, DETAILS ABOUT THE EXACT MEDICATION PRESCRIBED, ITS DOSAGE, AND THE LENGTH OF THERAPY REMAIN UNSPECIFIED. THE PATIENT IS RESPONDING TO TREATMENT, WITH NO SURGERY PLANNED. THE PATIENT REPORTS ONGOING POCKET PAIN BUT OTHERWISE FEELS UNCHANGED SINCE IMPLANT. THERE HAS BEEN NO REPORTED LOSS OR INTERRUPTION OF WISE THERAPY. HIGHER PACING THRESHOLDS WERE OBSERVED, WHICH MAY RESULT FROM INFECTION OR INFLAMMATION IN CERTAIN REGIONS. THERE IS CURRENTLY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Wound Infection

  MAUDE report 24449352 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE EBR REPRESENTATIVE INDICATING THAT THE PATIENT UNDERWENT EXPLANTATION OF THE CO-IMPLANTED DUAL CHAMBER ICD AND ATRIAL/RIGHT VENTRICULAR LEADS, AS WELL AS THE WISE BATTERY AND TRANSMITTER, DUE TO ENDOCARDITIS. THE PROCEDURE WAS REPORTEDLY COMPLETED SUCCESSFULLY BY DR. ROVARIS WITHOUT COMPLICATIONS. THE EXPLANTED WISE BATTERY AND TRANSMITTER ARE EXPECTED TO BE RETURNED TO EBR FOR EVALUATION. THE PATIENT ORIGINALLY UNDERWENT A DUAL-STAGE WISE CRT SYSTEM IMPLANT PROCEDURE IN (B)(6) 2020 FOLLOWING A FAILED CONVENTIONAL CORONARY SINUS LEAD IMPLANT. THE PATIENT SUBSEQUENTLY EXPERIENCED SIGNIFICANT SYMPTOMATIC IMPROVEMENT FOLLOWING WISE THERAPY INITIATION. IN (B)(6) 2025, THE PATIENT UNDERWENT A ROUTINE WISE BATTERY REPLACEMENT PROCEDURE. THE POST-OPERATIVE COURSE WAS LATER COMPLICATED BY RECURRENT INFECTION-RELATED ISSUES REQUIRING SEPARATE WISE BATTERY AND TRANSMITTER POCKET REVISION PROCEDURES, AS WELL AS PATIENT HOSPITALIZATION. ALTHOUGH INITIAL IMPROVEMENT AND EVIDENCE OF TRANSMITTER POCKET HEALING WERE OBSERVED AT THE (B)(6) 2026 FOLLOW-UP, THE PATIENT REPORTEDLY DISCONTINUED ANTIBIOTIC THERAPY FOR APPROXIMATELY ONE MONTH DUE TO SIGNIFICAN

  Patient problems: Wound Infection

  MAUDE report 23663083 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE (B)(6) 2025 OPTIMIZATION SESSION, NO TRACKING TO THE ELECTRODE WAS OBSERVED DESPITE AN 85% BIV PACING PERCENTAGE. NO TRACKING WAS ACHIEVED BESIDES A BRIEF PERIOD OF TRACKING AND BIV CAPTURE ABOUT 20 BEATS WHICH COULD NOT BE MAINTAINED OR REPLICATED FOR THE REMAINDER OF THE FOLLOW-UP. THE PATIENT WAS LATER FOUND TO HAVE A LARGE HEMATOMA AROUND THE BATTERY POCKET AND UNDERWENT A PLEURAL EFFUSION WITH GREATER THAN 2L OF FLUID REMOVED FROM THE LEFT PLEURAL CAVITY UNRELATED TO THE WISE PROCEDURE OR DEVICE. AFTER A TWO-WEEK RECOVERY, TRACKING AND BIV CAPTURE WERE RESTORED AT THE (B)(6) 2025 FOLLOW-UP, WITH CONSISTENT PERFORMANCE CONFIRMED DURING OPTIMIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23527856 ↗
• InjuryOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BATTERY POCKET PERFORATION WITH A POTENTIAL INFECTION RISK. THE PATIENT INITIALLY PRESENTED WITH MILD REDNESS AT THE INCISION SITE AND NO OVERT SIGNS OF INFECTION. OVER TIME, THE BATTERY ERODED THROUGH THE SKIN, RESULTING IN DEVICE EXPOSURE AND CREATING A POTENTIAL SITE FOR INFECTION. TO PREVENT INFECTION SPREAD, BOTH THE BATTERY AND TRANSMITTER WERE SUBSEQUENTLY REMOVED.

  Patient problems: Wound Infection

  MAUDE report 23375995 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED WOUND DEHISCENCE WITH BATTERY EROSION THROUGH THE SKIN. A DECISION REGARDING BATTERY REPLACEMENT WILL BE MADE FOLLOWING WOUND HEALING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Pocket Erosion; Unspecified Heart Problem; Wound Dehiscence

  MAUDE report 22986878 ↗