Confida™ GWBC30 (UDI 00763000758646)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000758646), received between Apr 25, 2025 and Sep 15, 2026 — classified as 6 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Device Dislodged or Dislocated; Positioning Problem; Patient Device Interaction Problem

  Patient problems: Aortic dissection

  MAUDE report 50780041 ↗
• InjuryJul 27, 2026Device Difficult to Setup or Prepare; Patient Device Interaction Problem

  It was reported that prior to the implant of a transcatheter aortic valve (TAV), during the loading phase, a bent strut was visually observed after "marrying" the tip guide tube and the outflow cone, constituting a misload. Subsequently, the valve was removed and the same delivery catheter system (DCS) and compression loading system (CLS) were used to load a new valve. Following the successful loading of the second valve, a Confida guidewire was inserted into the patient, and complete heart block (CHB) was observed. Temporary pacing was then initiated for the rest of the procedure. A pre-implant balloon aortic valvuloplasty (BAV) was performed with a non-Medtronic (Beckton Dickson True) 22 millimeter (mm) balloon, and the DCS was inserted into the patient via the right carotid artery. Following successful deployment of the valve, the temporary pacing was turn off, however the CHB remained. Subsequently, a permanent pacemaker was implanted. A procedural delay of 3 hours occurred as a result. Additional information was received to report the valve load was performed by an experienced valve loader. The misload was identified via visual inspection and was "seen early enough that we did

  Patient problems: Heart Block

  MAUDE report 50012469 ↗
• DeathApr 11, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED DUE TO CALCIFICATION. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE NATIVE AORTIC ANNULUS. THE VALVE WAS THEN PARTIALLY DEPLOYED IN THAT IT WAS POSITIONED APPROXIMATELY 4 MILLIMETERS (MM) FROM THE NON-CORONARY CUSP (NCC) AND 4 MM FROM THE LEFT CORONARY CUSP (LCC). DESPITE FOLLOWING TRAINING GUIDANCE FOR SLOW DEPLOYMENT OF THE VALVE AND CENTERING OF THE DCS NOSECONE BY SLIGHTLY RETRACTING THE GUIDEWIRE, THE NOSECONE SUDDENLY MOVED DURING FINAL DEPLOYMENT, CAUSING DCS INTERACTION WITH THE VALVE. THIS INTERACTION CAUSED THE VALVE TO EMBOLIZE INTO THE PATIENT'S ASCENDING AORTA. SUBSEQUENTLY, THE ATTENDING PHYSICIAN OPTED TO ATTEMPT IMPLANTATION OF A SECOND VALVE, SO A NEW VALVE WAS PREPARED AND LOADED INTO THE DCS. AS THE DCS WAS ADVANCED TOWARDS THE AORTIC ANNULUS, THE PREVIOUSLY DISLODGED VALVE BECAME UNSTABLE. THEREFORE, A SNARE WAS UTILIZED TO GRASP THE DISLODGED VALVE TO MAINTAIN ITS POSITION IN RELATION TO THE GREAT VESSELS AS THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED. AFTER IMPLANTATION OF THE SEC

  Patient problems: Cardiac Arrest; Pericardial Effusion; Rupture

  MAUDE report 24848153 ↗
• DeathJan 14, 2026Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A TRANSCATHETER VALVE, DURING DELIVERY CATHETER SYSTEM (DCS) ADVANCEMENT, THE DCS WAS DIFFICULT TO ADVANCE THROUGH THE PATIENT'S HEAVILY CALCIFIED AORTIC ARCH. AFTER SEVERAL ATTEMPTS, THE DCS WAS ABLE TO PASS AND THE VALVE WAS IMPLANTED. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND RECEIVED TREATMENT; HOWEVER, THE PATIENT DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE VALVE IMPLANT, THE STROKE WAS HEMORRHAGIC AND CONFIRMED BY PATIENT SYMPTOMS (LOSS OF CONSCIOUSNESS AND HEMIPARESIS) AND COMPUTED TOMOGRAPHY (CT). PER THE PHYSICIAN, THE VALVE DID NOT CONTRIBUTE TO THE STROKE BUT DUE TO VARIOUS ATTEMPTS TO CROSS THE CALCIFIED AORTIC ARCH THE DELIVERY CATHETER SYSTEM (DCS) MAY HAVE CONTRIBUTED TO CALCIUM DISPLACEMENT. THE CAUSE OF THE STROKE WAS CALCIUM DISPLACEMENT FROM THE AORTIC ARCH. THE PATIENT WAS HOSPITALIZED AND MEDICAL MANAGEMENT WAS USED TO TREAT THE STROKE. THE CAUSE OF DEATH WAS DUE TO THE STROKE.

  Patient problems: Stroke/CVA

  MAUDE report 24067535 ↗
• DeathJan 8, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER VALVE, UPON WITHDRAWING THE WIRE, THE VALVE WAS PULLED AND DISLODGED. A SNARE WAS USED TO STABILIZE THE DISLODGED VALVE IN THE ASCENDING AORTA, AND A SECOND VALVE WAS IMPLANTED. IMMEDIATELY AFTER THE IMPLANT OF THE SECOND VALVE, HYPOTENSION AND BRADYCARDIA WERE OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED A LARGE PERICARDIAL EFFUSION. SUBSEQUENTLY, RESUSCITATION WAS PERFORMED, INCLUDING CARDIAC MASSAGE, TEMPORARY PACING, AND PERICARDIAL DRAINAGE. EMERGENCY SURGERY WAS PERFORMED VIA LEFT ANTERIOR THORACOTOMY IN THE APICAL AREA. AT THE END OF THE PROCEDURE, BLEEDING HAD CEASED AND THE PATIENT WAS HEMODYNAMICALLY STABLE. APPROXIMATELY 5 HOURS FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT DIED. THE PHYSICIAN ASSESSED THAT DURING THE IMPLANT OF THE SECOND VALVE, THE MEDTRONIC (CONFIDA) GUIDEWIRE CAUSED A LEFT VENTRICLE PERFORATION THAT RESULTED IN TAMPONADE AND SUBSEQUENT DEATH. PER THE PHYSICIAN, THE EVENT WAS A PROCEDURE RELATED COMPLICATION, WITH NO CLAIMS AGAINST THE VALVE OR DELIVERY CATHETER SYSTEM (DCS). ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS NOT PERFORMED AND A

  Patient problems: Bradycardia; Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24006430 ↗
• InjuryNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, UPON PERFORMING HEMOSTASIS, FLUOROSCOPY REVEALED A DESCENDING AORTIC DISSECTION. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO UNDERGO A COMPUTED TOMOGRAPHY (CT) SCAN TO DETERMINE TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE DELIVERY CATHETER SYSTEM (DCS) AND MEDTRONIC GUIDEWIRE CAUSED THE DESCENDING AORTIC DISSECTION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND MEDICATION WAS ADMINISTERED TO TREAT THE DISSECTION. THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Aortic dissection

  MAUDE report 23533902 ↗
• DeathOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE VALVE WAS RECAPTURED TO REPOSITION IT; HOWEVER, THE PATIENT BEGAN TO DECOMPENSATE. SUBSEQUENTLY, CARDIAC MASSAGE AND CARDIOPULMONARY RESUSCITATION (CPR) WERE INITIATED. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED A PERICARDIAL EFFUSION, AND A PERFORATED/TORN VENTRICLE BY THE MEDTRONIC (CONFIDA) GUIDEWIRE. SUBSEQUENTLY, SURGICAL REPAIR WAS PERFORMED; HOWEVER, THE PATIENT DIED DURING THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO COMPLICATIONS WITH THE PERICARDIAL EFFUSION. IT WAS NOTED THAT THE TRANSCATHETER VALVE DID NOT CONTRIBUTE TO THE DEATH, AND WAS NEVER IMPLANTED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 23428215 ↗
• MalfunctionOct 17, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE GWBC30 CONFIDA 26L WAS FOUND TO BE FRAYED WHEN REMOVED FROM ITS ORIGINAL PACKAGING, AND AN ALLEGED PRODUCT ISSUE WAS IDENTIFIED. THE WIRE WAS NOT USED, AND THERE WAS NO EFFECT ON THE PATIENT. THE HEALTHCARE PROFESSIONAL SELECTED A NEW WIRE AND CONTINUED THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323695 ↗
• DeathJul 28, 2025Difficult or Delayed Positioning; Patient Device Interaction Problem; Difficult or Delayed Positioning; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN THOUGHT THAT SEQUESTRATION (WHEN THE CUSPS OF THE NATIVE AORTIC VALVE OR A PREVIOUS PROSTHESIS ARE DISPLACED BY THE NEW VALVE) OF THE SINUSES OF VALSALVA MAY HAVE OCCURRED WHICH MAY HAVE LEAD TO ACUTE CORONARY OBSTRUCTION.

  Patient problems: Coronary obstruction/occlusion; Hemodynamic instability; Low Blood Pressure/ Hypotension

  MAUDE report 22631800 ↗
• DeathApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VENTRICULAR PERFORATION WAS TREATED WITH PERICARDIOCENTESIS. PER THE PHYSICIAN, THE VALVE AND THE DCS COULD BE EXCLUDED AS CONTRIBUTING FACTORS TO THE DEATH. ADDITIONALLY, THE PATIENT HAD A SMALL LEFT VENTRICLE THAT CONTRIBUTED TO THE DEATH.

  Patient problems: Perforation

  MAUDE report 21912628 ↗