LunderquistRecalls & reported problems across all models
William Cook Europe ApS · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 3
- Injuries reported
- 12
- Recalls
- 0
We found 9 models of Lunderquist by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between May 12, 2016 and Feb 2, 2026 — classified as 3 deaths, 12 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Handling 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Lunderquist problems
Device problems
- Device Handling Problem9
- Device-Device Incompatibility3
- Flaked3
- Inadequacy of Device Shape and/or Size3
- Material Deformation3
- Unraveled Material3
- Detachment of Device or Device Component2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient5
- Vascular Dissection3
- Atrial Perforation2
- Death2
- Hemorrhage/Blood Loss/Bleeding2
- Cardiac Tamponade1
Lunderquist models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lunderquist G45408WIRE, GUIDE, CATHETER2 deaths11 reports
- Lunderquist G31453WIRE, GUIDE, CATHETER10 reports
- Lunderquist G45353WIRE, GUIDE, CATHETER6 reports
- Lunderquist G45208WIRE, GUIDE, CATHETER5 reports
- Lunderquist G46729WIRE, GUIDE, CATHETER2 reports
- Lunderquist G49227WIRE, GUIDE, CATHETER2 reports
- Lunderquist G53971WIRE, GUIDE, CATHETER1 death2 reports
- Lunderquist G49224WIRE, GUIDE, CATHETER1 report
- Lunderquist G49228WIRE, GUIDE, CATHETER1 report
Recent Lunderquist adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Structural Problem
ON (B)(6) 2025, THE PATIENT UNDERWENT AN EVAR PROCEDURE AS PART OF THE 17-07 ZENITH FENESTRATED+ ENDOVASCULAR GRAFT CLINICAL STUDY. ON (B)(6) 2025 (180 DAYS POST-PROCEDURE), THE 6M FOLLOW-UP CT IMAGING WAS COMPLETED. PER SITE REVIEW, THE ENDOGRAFT DEVICES AND VISCERAL VESSELS WITHIN STENT AND NATIVE VESSEL WERE PATENT. THERE WAS NO STENOSIS >50% IN ANY TREATED VESSEL. THERE WAS NO ENDOLEAK, SEPARATION OF COMPONENTS, NO EVIDENCE OF MIGRATION, EVIDENCE OF DEVICE INTEGRITY ISSUE, OR EVIDENCE OF THROMBUS WITHIN A STUDY DEVICE. PER CORE LAB REVIEW, THE ENDOGRAFT DEVICES WERE PATENT, THERE WAS NO STENOSIS OF THE BILATERAL ILIAC LEG GRAFTS OR VISCERAL VESSELS. THERE WAS NO ENDOLEAK, NO SEPARATION OF COMPONENTS, NO EVIDENCE OF MIGRATION, AND NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THERE WAS EVIDENCE OF THROMBUS WITHIN UNIBODY2 WHICH WAS AN INITIAL FINDING. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH AN ARTERIAL DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. THE EVENT IS ONGOING AND WILL BE TREATED ON (B)(6) 2026 WITH A STENT PLACEMENT. THE SITE CONSIDERED THE EVENT PROBABLY RELATED TO THE RIGHT ZSLE ILIAC LEG GRAFT, NOTING ¿ARTERIAL INJURY DUE TO PASSAGE OF DEVICE WITH GRADUAL OCCLUSIO
Patient problems: Vascular Dissection
MAUDE report 24234320 ↗MalfunctionNov 27, 2025Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665669 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656227 ↗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 ↗MalfunctionJun 23, 2025Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE, A MERIT 'S 6F ARTERIAL SHEATH WAS PLACED, AND A COMMON LOACH GUIDEWIRE WAS ENTERED ALONG THE ARTERIAL SHEATH UP TO THE ASCENDING AORTA, AND THEN REPLACED WITH CATHETER (N5.0-35-100-P-10S-PIG-CSC-20), CONTRAST, AND REPLACED WITH A WIRE GUIDE (TSMG-35-260-LES )TO THE AORTIC SINUS, AND THE PROXIMAL END OF THE WIRE GUIDE APPEARED TO BE BENT, AND IMMEDIATELY WITHDRAW THE TSMG-35-260-LES GUIDEWIRE WITH THE N5.0-35-100-P-10S-PIG-CSC-20 CATHETER, REPLACE IT WITH A NEW TSMG-35-260-LES, AND THEN PROCEED WITH COMPRESSION DEVICE IMPLANTATION, RELEASE OF THE VALVE, REPLACEMENT OF THE N5.0-35-100-P-10S-PIG-CSC-20, AND IMAGING TO CONFIRM THAT THE PROCEDURE WENT WELL AND THAT THE PATIENT CONDITION IMPROVED AND ENDED THE SURGERY. PATIENT OUTCOME. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306777 ↗MalfunctionJun 16, 2025Fracture; Fracture
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE, THE WIRE GUIDE FAILS TO PASS THROUGH THE LESION. REPLACEMENT OF THE WIRE GUIDE TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210391 ↗MalfunctionMay 30, 2025Material Deformation; Device Handling Problem; Material Deformation; Device Handling Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113195 ↗MalfunctionMar 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
DESCRIPTION OF EVENT ACCORDINGH TO INITIAL REPORTER: THE WIRE WAS INSERTED INTO THE NON-COOK PIGTAIL CATHETER AND WOULD NOT COME OUT. THE TIP FRAYED AND CAME OFF THE WELLPOINT, THE WHOLE SYSTEM HAD TO BE REMOVED. ANOTHER OF THE SAME DEVICES WERE USED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584002 ↗MalfunctionFeb 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363762 ↗MalfunctionFeb 12, 2025Device Handling Problem; Device Handling Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362543 ↗InjuryOct 21, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE OUTSIDE OF THE GUIDEWIRE HAS BECOME LOOSE AND AS A RESULT, HAS BECOME STUCK IN THE GRAFT. CONVERSION WAS NECESSARY. PER COMPLAINT FORM: THE LUNDERQUIST WAS BROUGHT IN, A MEDTRONIC DELIVERY SYSTEM WAS BROUGHT IN OVER THE WIRE, ALL NORMAL STEPS WERE DONE. DURING BRINGING IN THE CONTRAL LATERAL LEG THE WIRE WAS STUCK IN THE DELIVERY SYSTEM. PULLING OUT WAS NOT POSSIBLE. PATIENT WAS CONVERTED TO AN OPEN PROCEDURE, EVERYTHING WAS TAKEN OUT AND THE PATIENT RECEIVED A SURGICAL GRAFT. BOTH MAIN DEVICE AND CONTROL LATERAL LEG WERE ALREADY DEPLOYED WHEN THE LUNDERQUIST WAS STUCK IN THE MEDTRONIC DEVICE. CLINICAL SPECIALIST FROM MEDTRONIC SAID THE WIRE WAS OVER THE BIFURCATION, BUT IN THE ATTACHED VIDEO THE WIRE IS IN THE AORTA. NOBODY UNDERSTOOD WHY THE WIRE WAS STUCK, ALL NORMAL STEPS WERE TAKEN. PATIENT OUTCOME: AFTER OPEN PROCEDURE, ALL PARTS HAVE BEEN TAKEN OUT. AN ENDOVASCULAR AORTIC REPAIR (EVAR) WAS CONVERTED TO AN OPEN PROCEDURE IN ORDER TO REMOVE THE STENT FROM MEDTRONIC AND LUNDERQUIST WIRE. BECAUSE OF THE PRODUCT FAILURE AN OPEN PROCEDURE WAS PERFORMED, PATIENT WENT TO IC AFTERWARDS.
Patient problems: Insufficient Information
MAUDE report 20491289 ↗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 ↗DeathMar 23, 2022Positioning Problem; Positioning Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER AN APPROACH FROM THE RIGHT FEMORAL ARTERY WAS GAINED WITH THE FIRST TSCMG-35-300-E-LESDC(E4202485), THE TWO ZENITH THORACIC ALPHA (ZTA-PT-36-32-209-W1/E4055076 AND ZTA-PT-32-28-201-W1/E4211066) WERE PLACED FROM JUST BELOW THE LEFT COMMON CAROTID ARTERY TO JUST ABOVE THE CELIAC ARTERY (FOR THE PRIMARY ENTRY CLOSURE). THEREAFTER, THE TWO ENDURANT II AORTIC EXTENSIONS WERE PLACED IN THE ABDOMINAL AORTA (FOR RE-ENTRY CLOSURE). DUE TO ALLERGY TO CONTRAST MEDIA, IVUS (INTRAVASCULAR ULTRASOUND) WAS USED TO CONFIRM THE POSITION OF THE BRANCHES. FOUR OF THE ABOVE STENT GRAFTS WERE IMPLANTED IN THE PLANNED POSITION. DUE TO THE NARROWING OF THE TRUE LUMEN OF THE DESCENDING AORTA, THERE WAS A NEED TO ENHANCE THE FITTING OF THE THORACIC ALPHA JUNCTION. SO, AFTER AN APPROACH FROM THE LEFT FEMORAL ARTERY WAS GAINED WITH THE SECOND TSCMG-35-300-E-LESDC(E4202485), TOUCH UP WITH A CODA BALLOON (CODA-2-10.0-35-120-40/14095690) WAS PLANNED TO BE PERFORMED. AN APPROACH FROM LEFT FEMORAL ARTERY WAS GAINED, THE REPORTED CODA BALLOON CATHETER COULD NOT BE ADVANCED DUE TO HIGH DEGREE OF TORTUOSITY OF DESCENDING AORTA,. INJURY/TEAR (RUPTURE) OCCURRED
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 13859837 ↗MalfunctionFeb 1, 2022Device Handling Problem; Device Handling Problem
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE END TIP OF THE WIRE GUIDE FALL OFF, THEN A NEW WIRE GUIDE WAS REPLACED AND COMPLETED THE PROCEDURE SUCCESSFULLY. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13410769 ↗
Other William Cook Europe ApS products
All William Cook Europe ApS devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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