Lunderquist G45408Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002454088), received between Jun 16, 2017 and Nov 18, 2025 — classified as 2 deaths, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 23579615 ↗
• MalfunctionSep 5, 2025Material Deformation; Device Handling Problem; Material Deformation; Device Handling Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2025, IN THE INTERVENTIONAL CARDIOLOGY ROOM, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, IT WAS NOTED THAT THE GUIDE REMAINED STUCK IN THE DILATOR, CAUSING DIFFICULTIES IN REMOVAL, CAUSING THE GUIDE TO COMPLETELY FRAY. THIS INCIDENT COULD HAVE RESULTED IN LOSS OF THE SURGICAL APPROACH OR EVEN EMBOLIZATION. A DEVICE OF THE SAME REFERENCE AND UNKNOWN LOT WAS USED TO CONTINUE THE PROCEDURE. PATIENT OUTCOME: THE 81-YEAR PATIENT SUFFERED NO CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975904 ↗
• InjuryJan 3, 2023Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN ATTEMPTED TO DELIVER ZTA-P-34-161-W1 TO TARGET SITE AT THE ARCH AORTA OVER LUNDERQUIST TSCMG-35-300-LESDC APPROACHING FROM RIGHT CFA, HE FELT THE RESISTANCE OF SCRAPING AND DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM. THEREFORE HE FIXED A WIRE GUIDE WITH ANOTHER PHYSICIAN AND PUSHED AND ADVANCED BY FORCE TO PLACE IT. WHEN THEY ATTEMPTED TO PLACE ZTA-DE-34-112-W1, THEY ALSO FELT SAME DIFFICULTY AND PLACED BY FORCE. THERE WAS A ABNORMALITY ABOUT 10 CM FROM THE TIP. IT SEEMED THAT THERE WAS A DEFECT OF COATING OF WIRE GUIDE OR COIL. PATIENT OUTCOME: NO HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085022 ↗
• MalfunctionJun 15, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE INITIAL REPORTER: TEVAR WAS PERFORMED AND THE WIRE GUIDE WAS INSERTED IN THE BODY. THE USER TRIED TO ADVANCE A GORE'S CTAG 40MMX15MM ((B)(4)) OVER THE WIRE BUT THE WIRE COULD NOT BE INSERTED AT ALL. THE USER THOUGHT THAT THE PROBLEM WAS EITHER THE SIZE OF THE WIRE OR THE WIRE LUMEN OF THE CTAG, THE LUNDERQUIST WAS REPLACED FIRST, AND AFTER ANOTHER LUNDERQUIST WAS PLACED, THE CTAG PASSED THROUGH, SO IT WAS CONCLUDED THAT THE PROBLEM WAS ON THE FIRST WIRE GUIDE. THE CTAG WAS PLACED AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THE INITIAL REPORTER HAS NOT REPORTED ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998293 ↗
• InjuryOct 8, 2020Device Handling Problem; Device Handling Problem

  DESCRIPTION OF EVENT ACCORDING TO MEDWATCH 0700280000-2020-8016: PATIENT WAS UNDERGOING NON-SURGICAL AORTIC VALVE REPLACEMENT (AVR) WITH A 26MM COREVALVE. USING A RETROGRADE PERCUTANEOUS APPROACH FOR A TRANSCATHETER AORTIC VALVE. A 035/180CM LUNDERQUIST EXTRA STIFF WIRE WAS ADVANCED RETROGRADE ACROSS THE AORTIC VALVE TO THE LEFT VENTRICULAR APEX. AFTER THE DELIVERY OF THE BALLOON AORTIC VALVULOPLASTY, THE LUNDERQUIST WIRE WAS NOTED TO HAVE A ABNORMAL BAND APPROXIMATELY 40MM FROM THE DISTAL TIP AT THE SEGMENT OF THE WIRE THAT IS GENERALLY BONDED. AT THIS POINT THE PHYSICIAN BECAME CONCERNED GIVEN THE ABNORMAL APPEARANCE OF THE WIRE FOR TRAUMA TO THE LEFT VENTRICLE. A STRAIGHT PIGTAIL WAS DELIVERED, AND THE WIRE WAS EXCHANGED FOR A NEW ONE. THE INITIAL WIRE WAS EXAMINED, AND THERE WAS NO EVIDENCE OF DISRUPTION OF THE OUTER CORE, IT JUST SIMPLE APPEARED TO HAVE BENT SLIGHTLY. IN CAUTION, AN ECHO WAS PERFORMED, AND IT WAS NOTED FOR A PERICARDIAL EFFUSION, PATIENT WAS STABLE DURING PROCEDURE, CONSULT PLACED TO CV SURGEON, PATIENT BROUGHT TO OR FOR SUBXIPHILD PERICARDIAL WINDOW FOLLOWED BY STERNOTOMY, CARDIOPULMONARY BYPASS, AND REPAIR LEFT VENTRICULAR PERFORATION. PER OR REPORT, THERE W

  Patient problems: Atrial Perforation

  MAUDE report 10648857 ↗
• InjuryOct 8, 2020Device Handling Problem; Device Handling Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WAS UNDERGOING NON-SURGICAL AORTIC VALVE REPLACEMENT (AVR) WITH A 26MM COREVALVE. USING A RETROGRADE PERCUTANEOUS APPROACH FOR A TRANSCATHETER AORTIC VALVE. A 035/180CM LUNDERQUIST EXTRA STIFF WIRE WAS ADVANCED RETROGRADE ACROSS THE AORTIC VALVE TO THE LEFT VENTRICULAR APEX. AFTER THE DELIVERY OF THE BALLOON AORTIC VALVULOPLASTY, THE LUNDERQUIST WIRE WAS NOTED TO HAVE A ABNORMAL BAND APPROXIMATELY 40MM FROM THE DISTAL TIP AT THE SEGMENT OF THE WIRE THAT IS GENERALLY BONDED. AT THIS POINT THE PHYSICIAN BECAME CONCERNED GIVEN THE ABNORMAL APPEARANCE OF THE WIRE FOR TRAUMA TO THE LEFT VENTRICLE. A STRAIGHT PIGTAIL WAS DELIVERED AND THE WIRE WAS EXCHANGED FOR A NEW ONE. THE INITIAL WIRE WAS EXAMINED AND THERE WAS NO EVIDENCE OF DISRUPTION OF THE OUTER CORE, IT JUST SIMPLE APPEARED TO HAVE BENT SLIGHTLY. IN CAUTION, AN ECHO WAS PERFORMED AND IT WAS NOTED FOR A PERICARDIAL EFFUSION, PATIENT WAS STABLE DURING PROCEDURE, CONSULT PLACED TO CV SURGEON, PATIENT BROUGHT TO OR FOR SUBXIPHILD PERICARDIAL WINDOW FOLLOWED BY STERNOTOMY, CARDIOPULMONARY BYPASS, AND REPAIR LEFT VENTRICULAR PERFORATION. PER OR REPORT, THERE WAS A 1 CM, LACER

  Patient problems: Atrial Perforation

  MAUDE report 10647881 ↗
• MalfunctionSep 17, 2019Material Twisted/Bent; Material Twisted/Bent

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TEVAR WAS BEING PERFORMED WITH ANOTHER MANUFACTURER¿S STENT GRAFT. FIRST, A WIRE GUIDE (FROM ANOTHER MANUFACTURER) AND A CATHETER WERE ADVANCED TO THE AORTIC VALVE. THEN, THE PHYSICIAN ATTEMPTED TO EXCHANGE THE WIRE GUIDE FOR THE COMPLAINT (B)(4) WITH THE RIGHT APPROACH. HOWEVER, IT GOT KINKED LIKELY DUE TO THE SEVERE ANGULATION AT THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THAT, ANOTHER (B)(4) WAS SUBSTITUTED FOR THE COMPLAINT ONE. THE SUBSTITUTE ONE COULD BE DELIVERED WITHOUT GETTING KINK. THE KINK DID NOT HAVE SHARP EDGES. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9074378 ↗
• DeathJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Death; Vascular Dissection

  MAUDE report 8801660 ↗
• DeathJul 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Cardiac Tamponade; Death; Perforation

  MAUDE report 8751869 ↗
• InjuryDec 4, 2018Flaked; Flaked

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8127841 ↗
• InjuryJun 16, 2017Difficult to Advance; Difficult to Advance

  A MALE PATIENT UNDERWENT TEVAR. ACCESS WAS GAINED FROM RIGHT COMMON ILIAC ARTERY (CIA), SINCE ACCESS VESSEL WAS TOO THIN. AFTER SECURE THE ACCESS ROUTE, THE WIRE GUIDE WAS EXCHANGED FOLLOWED BY ANGIOGRAPHY. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM OVER THE WIRE GUIDE, HOWEVER, IT COULD NOT BE ADVANCED. THEREFORE, ANOTHER WIRE GUIDE (TSCMG-35-260-E-LESDC/LOT# UNKNOWN) WAS USED INSTEAD, AND IT PASSED THROUGH THE DEVICE SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. STATED BY THE PHYSICIAN: "THE WIRE GUIDE WAS NOT EVEN KINKED, HOWEVER IT COULD NOT BE PASSED THROUGH THE DELIVERY SYSTEM. I SUSPECT THAT THE WIRE GUIDE HAS INDIVIDUAL DIFFERENCE OR IT WAS THICK ORIGINALLY". PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645934 ↗