EVOQUE 9850EV44USRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00690103217445), received between May 20, 2024 and May 7, 2026 — classified as 2 deaths, 20 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (18 reports).

1 other recall cover devices cleared under the same FDA submission (P230013); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. ON POST OPERATIVE DAY (POD) 50, THE PATIENT PRESENTED IN CLINIC POST-TTVR WITH BIOPROSTHETIC VALVE STENOSIS AND ACUTE HEART FAILURE. ON FOLLOW-UP EVALUATION, THE REPORTED MECHANISM OF VALVE FAILURE WAS THROMBOSIS, PER PHYSICIAN. IT WAS CONFIRMED THAT THE PATIENT HAD BEEN ANTICOAGULATED. THE PATIENT WAS TREATED WITH IV HEPARIN AND WAS DISCHARGED AFTER FAILING TO SHOW SIGNIFICANT CLINICAL IMPROVEMENT DESPITE TREATMENT WITH IV HEPARIN. THE PHYSICIAN DECIDED TO FURTHER TREAT THE PATIENT BY IMPLANTING ANOTHER VALVE WITHIN THE EXISTING EVOQUE VALVE. SUBSEQUENTLY, THE VALVE IN VALVE WAS PERFORMED ON POD 57 AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25111468 ↗
• DeathApr 30, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT AFTER IMPLANTATION OF EVOQUE DEVICE MODEL 9850EV44US 44MM WAS IMPLANTED IN THE TRICUSPID POSITION, THAT THE PATIENT IS DECEASED. ALTHOUGH IT WAS INDICATED THAT THE PATIENT DID NOT HAVE A CONDUCTION DISTURBANCE PRIOR TO EVOQUE IMPLANT, ADDITIONAL INFORMATION INDICATED THAT, THE PATIENT REQUIRED EP MONITORING POST EVOQUE IMPLANT. AS A RESULT, THERE WAS SOME SORT OF CONDUCTION/ ARRYTHMIA REQUIRING MONITORING PRIOR TO THE DEATH. PATIENT DIED FROM SINUS ARREST ON POST OPERATIVE DAY (POD) 9. PHYSICIAN INDICATED DEATH WAS NOT RELATED TO DEVICE MALFUNCTION.

  Patient problems: Arrhythmia

  MAUDE report 25050174 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DURING THE PROCEDURE, THE PATIENT WENT INTO COMPLETE HEART BLOCK AFTER DEPLOYMENT OF THE VALVE. TEMPORARY PACING INTERVENTION WAS PERFORMED FOLLOWED BY AN IMPLANTATION OF A LEADLESS PERMANENT PACEMAKER IMMEDIATELY AFTER THE EVOQUE PROCEDURE. THE PATIENT IS IN STABLE CONDITION. THE PATIENT DID NOT HAVE ANY CONDUCTION DISTURBANCE PRIOR TO THE PROCEDURE. NO MANEUVERS TRIGGER RHYTHM CHANGE. THE FINAL VALVE DEPLOYMENT POSITION WAS ANNULAR. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT IS COMPLETE HEART BLOCK AFTER DEPLOYMENT OF THE EVOQUE VALVE.

  Patient problems: Heart Block

  MAUDE report 24735115 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PATIENT WAS VERY SENSITIVE TO THE WIRE HAVING EPISODES OF RVR IN THE BEGINNING. DURING THE PROCEDURE BEFORE FINAL DEPLOYMENT THERE WERE TWO EPISODES OF BRADYCARDIA ASSOCIATED WITH A LOW BLOOD PRESSURE, BUT IT WAS STABILIZED BY ANESTHESIA. THE VALVE WAS IMPLANTED IN GOOD POSITION. HOWEVER, SEVERAL MINUTES AFTER DEPLOYMENT, PATIENT WENT INTO AVB THEN ASYSTOLE. THE PATIENT WAS SHOCKED INTO A RHYTHM, A TEMP PACER WAS PLACED AND THE PATIENT WAS SENT TO CVICU. A PERMANENT PACER WAS PLACED WITH LEAD ACROSS VALVE. THE PATIENT WAS DISCHARGED HOME ON DAY 3 AND REMAINED STABLE.

  Patient problems: Heart Block

  MAUDE report 24327446 ↗
• InjuryJan 28, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. FOLLOWING EVOQUE VALVE DEPLOYMENT, A CONDUCTION DISTURBANCE WAS NOTED DURING REMOVAL OF THE DELIVERY SYSTEM, WITH THE VALVE POSITIONED AT 0-5 MM AND REMAINING STABLE. THE PATIENT DEVELOPED UNRESOLVED 2:1 HEART BLOCK, AND DUE TO LOW HEMODYNAMICS, RE-HEPARINIZATION WAS AVOIDED. A PERMANENT PACEMAKER WAS IMPLANTED ON SAME DAY POST DEPLOYMENT.

  Patient problems: Heart Block

  MAUDE report 24205717 ↗
• InjuryDec 19, 2025Malposition of Device; Malposition of Device

  EDWARDS WAS NOTIFIED OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) USING THE EVOQUE SYSTEM. DURING THE PROCEDURE, MANEUVERS WERE PERFORMED TO RELEASE WHAT APPEARED TO BE THE ANTERIOR LEAFLET, LATER SUSPECTED TO BE A CHORDAE. AFTER VALVE RELEASE, THE DEVICE CANTED ANTERIORLY, CAUSING MINOR PARAVALVULAR LEAK WITHOUT CENTRAL LEAK. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED USING A SAPIEN TAVR, WITH THE EVOQUE VALVE HELD IN PLACE BY A SNARE DURING DEPLOYMENT. THE VALVE DROP WAS UNEXPECTED AND MAY HAVE RESULTED FROM INCOMPLETE ANTERIOR LEAFLET CAPTURE, POSSIBLY INVOLVING A CHORDAE. THE PATIENT REMAINED STABLE AND WAS PREPARING FOR DISCHARGE.

  Patient problems: Insufficient Information

  MAUDE report 23857373 ↗
• InjuryNov 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. AT FINAL VALVE DEPLOYMENT, THE VALVE WAS WELL SEATED AT ANNULUS IN ALL ASPECTS. THE DELIVERY SYSTEM WAS CAREFULLY NAVIGATED OUT TO THE RIGHT ATRIUM. ONE MINUTE AFTER VALVE DEPLOYMENT, THE PATIENT DEVELOPED COMPLETE HEART BLOCK AND ASYSTOLE. AN INTERNAL TEMPORARY VENOUS PACEMAKER WAS PLACED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 23624220 ↗
• InjuryNov 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE RHYTHM CHANGED DURING THE PROCEDURE TO ASYSTOLE THEN CONVERTED INTO HEART BLOCK WITH ESCAPE RHYTHM. THE ARRHYTHMIA WAS NOTED UPON DEPLOYMENT. NO MANEUVERS TRIGGERED THE RHYTHM CHANGE. TEMP PACER WAS PLACED WITH A PLAN TO IMPLANT A PERMANENT PACEMAKER THE NEXT DAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE VALVE WAS AT ANNULAR LEVEL AS THE FINAL DEPLOYMENT POSITION. THE VALVE WAS NOT TOO VENTRICULAR.

  Patient problems: Heart Block

  MAUDE report 23511062 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE VALVE WAS DEPLOYED WITH NO ISSUES. THE PATIENT DID RECEIVE TEMP PACER POST IMPLANT, SOMEWHERE BETWEEN 5-30 MINUTES POST IMPLANT FOR HEART BLOCK. THE CONDUCTION DISTURBANCE WAS NOTED 5-30 MINUTES AFTER IMPLANT. THERE WERE NO CONDUCTION DISTURBANCES BEFORE OR DURING IMPLANT. THE BASELINE RHYTHM IS NOT KNOWN.

  Patient problems: Heart Block

  MAUDE report 23439403 ↗
• InjuryOct 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE PATIENT WENT INTO INTERMITTENT COMPLETE HEART BLOCK DURING WIRE PLACEMENT WITHOUT THE DELIVERY INSERTED IN PATIENT. A TEMPORARY PACING WIRE WAS PLACED IN RIGHT VENTRICLE (RV) AT P/S COMM TO PACE THE PATIENT DURING INTERMITTENT COMPLETE HEART BLOCK WHILE THE WIRE AND DELIVERY SYSTEM WERE PLACED ACROSS TVA AND INTO RV. THE PATIENT WENT INTO SUSTAINED COMPLETE HEART BLOCK WHEN ANCHORS GOT EXPOSED TO 90 DEGREES. PACING WAS PERFORMED THROUGHOUT EVOQUE DEPLOYMENT VIA TEMP PACEMAKER SITTING IN P/S COMM AND A PERMANENT PACEMAKER WAS PLACED THROUGH EVOQUE VALVE INTO RV SEPTUM AFTER FINAL DEPLOYMENT.

  Patient problems: Heart Block

  MAUDE report 23398598 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE PATIENT WENT INTO COMPLETE HEART BLOCK 5 MINUTES POST DEPLOYMENT WHICH WAS SHORTLY AFTER EXTUBATION. AN INTERNAL TEMPORARY VENOUS PACEMAKER WAS IMPLANTED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT IS VALVE INTERACT WITH CONDUCTION SYSTEM. THE FINAL VALVE DEPLOYMENT WAS THE CORRECT POSITION.

  Patient problems: Heart Block

  MAUDE report 23337475 ↗
• InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE ON POST OPERATIVE DAY 1 THE PATIENT WAS REPORTED TO HAVE A CONDUCTION DISTURBANCE. A PERMANENT PACEMAKER WAS PLACED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE FINAL VALVE DEPLOYMENT POSITION WAS CENTRAL AND COAXIAL IN THE TVA.

  Patient problems: Bradycardia

  MAUDE report 23051916 ↗
• InjuryJul 29, 2025Migration; Intravalvular regurgitation; Migration; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE ON POST OPERATIVE DAY (POD) 1 ON THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) IT WAS OBSERVED THE SEPTAL APPEARED LOWER AS THE FINAL POSITION OF THE VALVE AND THE CENTRAL REGURGITATION WAS NOTED TO HAVE PROGRESSED TO MODERATE TO SEVERE. PREVIOUSLY, THE PATIENT HAD MODERATE PVL POSTERIORLY AND MILD CENTRAL REGURGITATION POST-DEPLOYMENT. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT AND NO ACTIONS TAKEN. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION. RELATIVELY UNEVENTFUL PROCEDURE WITH SOME CATHETER SHADOWING. THE LEAFLET CAPTURE CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN. POSTERIOR LEAFLET PINNING OBSERVED POST DEPLOYMENT. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE. THE VALVE DID EXPAND EVENLY AND AS EXPECTED DURING VENTRICULAR AND ATRIAL EXPANSION STAGES. THERE WAS APPROPRIATE VOLUME OPTIMIZATION THE DAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646461 ↗
• InjuryJul 21, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM, WHICH WAS COMPLICATED BY RIGHT VENTRICULAR (RV) PERFORATION, VALVE EMBOLIZATION, AND THE NEED FOR SURGICAL INTERVENTION INCLUDING BIOPROSTHETIC VALVE REPLACEMENT AND PERMANENT PACEMAKER (PPM) PLACEMENT. DURING THE PROCEDURE, AFTER REACHING FULL WHITE KNOB, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. IMAGING REVEALED A PERICARDIAL EFFUSION, AND PERICARDIOCENTESIS WAS PERFORMED TO RELIEVE TAMPONADE. THE VALVE WAS THEN QUICKLY DEPLOYED WHILE THE PATIENT'S RV EXHIBITED AKINESIS WITH ABSENT CONTRACTILE FUNCTION. AT THIS TIME, THE EFFUSION REACCUMULATED, REQUIRING ADDITIONAL DRAINAGE. DURING CATHETER WITHDRAWAL, THE EVOQUE VALVE EMBOLIZED INTO THE VENTRICLE. EMERGENCY SURGERY WAS INITIATED. THE PATIENT WAS PLACED ON ECMO, STABILIZED, AND TRANSFERRED TO THE OPERATING ROOM, WHERE AN RV APICAL PERFORATION WAS REPAIRED. THE EMBOLIZED EVOQUE VALVE WAS REMOVED, AND A SURGICAL BIOPROSTHETIC VALVE WAS IMPLANTED. A PERMANENT PACEMAKER (PPM) WAS ALSO PLACED. A PIGTAIL CATHETER WAS INITIALLY USED FOR WIRE PLACEMENT AT THE RV APEX, BUT WIRE POSITION WAS LOST DURING MANIPUL

  Patient problems: Foreign Body Embolism

  MAUDE report 22559601 ↗
• InjuryMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE ON POST OPERATIVE DAY 0, THE PATIENT WENT INTO HEART BLOCK AND NEEDED A PERMANENT LEADLESS PACEMAKER IMPLANT. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 22107700 ↗
• InjuryMay 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE UPON RELEASE OF THE EVOQUE VALVE, THE PATIENT HAD COMPLETE HEART BLOCK WITH A JUNCTIONAL RHYTHM THAT RANGED FROM 35-50BPM. EPI WAS ADMINISTERED AND RATE INCREASED TO 70-90BPM. A TEMPORARY PACING WIRE WAS PLACED VIA JUGULAR ACCESS. PLACEMENT OF TEMP PACING WIRE TOOK PLACE AT THE END OF THE PROCEDURE AND CARE TEAM WILL MONITOR RHYTHM TO SEE IF A PERMANENT PACEMAKER IMPLANTATION WILL BE REQUIRED.

  Patient problems: Heart Block

  MAUDE report 22020814 ↗
• DeathApr 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE ON POST-OPERATIVE DAY 6, AFTER THE EVOQUE PROCEDURE, THE PATIENT DIED. THIS PATIENT WAS DISCHARGED HOME AFTER RECEIVING THE EVOQUE VALVE. THE PATIENT WENT TO THE EMERGENCY ROOM AT AN OUTSIDE SMALLER HOSPITAL IN COMPLETE HEART BLOCK (AV BLOCK), UNABLE TO TRANSCUTANEOUSLY PACE RESULTING IN DEATH.

  Patient problems: Heart Block

  MAUDE report 21895111 ↗
• InjuryFeb 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE UPON FINAL RELEASE OF THE VALVE, THE PATIENT WENT INTO COMPLETE HEART BLOCK. PATIENT WAS PACED VIA EXTERNAL PADS UNTIL A TEMPORARY WIRE WAS FLOATED THROUGH THE VALVE TO TRANSPORT THE PATIENT TO THE ELECTROPHYSIOLOGY (EP) LAB FOR A CORONARY SINUS (CS) LEAD.

  Patient problems: Heart Block

  MAUDE report 21402311 ↗
• InjuryJan 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE ON POST-OPERATIVE DAY (POD) 0, TEMPORARY PACING INTERVENTION WAS REQUIRED. ON POD 1, A LEADLESS PACEMAKER WAS IMPLANTED 'SECONDARY TO HEAR PAUSES, AND ELEVATED RISK OF PROGRESSION TO COMPLETE HEART BLOCK PER OUR EP TEAM.'

  Patient problems: Heart Block

  MAUDE report 21187669 ↗
• InjuryNov 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE TWO HOURS POST PROCEDURE, THE PATIENT DEVELOPED HEART BLOCK AND A TEMPORARY PACING WIRE WAS INSERTED. ON POD 1, THE PATIENT RECEIVED A PERMANENT LEADLESS PACEMAKER.

  Patient problems: Heart Block

  MAUDE report 20792451 ↗
• InjuryNov 5, 2024Migration; Intravalvular regurgitation; Migration; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE IT WAS REPORTED THAT THE VALVE MALPOSITIONED POST DEPLOYMENT. DURING THE PROCEDURE, THE PLACEMENT WAS SOMEWHAT DEEP AFTER INITIAL CROSSING BUT WIRE PUSH ACHIEVED ADEQUATE HEIGHT FOR CAPSULE GAP AND SUBSEQUENT CAPSULE REVEAL. SOME MILD COMPROMISES ON POSITION AND TRAJECTORY BUT QUITE STRAIGHTFORWARD FOR AN INTERNAL JUGULAR APPROACH. CARCINOID LEAFLETS ALLOWED FOR LEAFLET CAPTURE VERY EARLY IN ANCHOR REVEAL AND THE TEAM WAS ABLE TO BRING THE VALVE NEAR THE ANNULAR PLANE FOR FULL VALVE DEPLOYMENT. AFTER RELEASE OF THE VALVE, IT SETTLED MORE VENTRICULAR MOST PROMINENTLY IN ANTERIOR/SEPTAL ASPECT. VALVE NOTED TO BE STABLE BUT WITH MILD-MODERATE PVL ANTERIOR/SEPTAL, AND MODERATE-SEVERE CENTRAL REGURGITATION. ADDITIONALLY, THERE LOOKED TO BE SOME SLUGGISHNESS OF THE EVOQUE LEAFLETS RESULTING IN REGURGITATION. NO INTERVENTION PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 20615823 ↗
• InjuryMay 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT EXPERIENCED COMPLETE HEART BLOCK ON POST OP DATE (POD) 1, WHICH REQUIRED PLACEMENT OF A PERMANENT PACEMAKER ON (POD) 3. EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE POST PROCEDURE, PATIENT DEVELOPED RIGHT BUNDLE BRANCH BLOCK (RBBB). ON (POD) 1, IT WAS REPORTED THE PATIENT DEVELOPED COMPLETE HEART BLOCK AND A TEMPORARY PACEMAKER WAS PLACED. ON (POD) 3, A PERMANENT PACEMAKER WAS PLACED VIA TEE GUIDANCE WITH A SMALL SEPTAL LEAD THROUGH EVOQUE VALVE.

  Patient problems: Heart Block

  MAUDE report 19353243 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P230013. One submission often covers many models, so check the product and lot details in each record.

• Z-2172-2026 · Mar 27, 2026 · Open, Classified
  Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO