Lunderquist G31453Recalls & reported problems
William Cook Europe ApS · Lunderquist, Extra Stiff Wire Guide · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002314535), received between Jun 23, 2016 and Feb 2, 2026 — classified as 1 injury, 9 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.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem3
- Material Deformation2
- Component Missing1
- Device-Device Incompatibility1
- Fracture1
- Improper or Incorrect Procedure or Method1
- Material Perforation1
- Metal Shedding Debris1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
- Vascular Dissection1
Recent adverse event reports
The 10 most recent of 10 reports, 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 ↗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 ↗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 ↗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 ↗MalfunctionDec 7, 2017Material Perforation; Material Perforation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WIRE GUIDE BROKEN DURING OPERATION. PATIENT OUTCOME: 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 Known Impact Or Consequence To Patient
MAUDE report 7094761 ↗MalfunctionJul 10, 2017Premature Activation; Premature Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER OPENED THE PACKAGE FOUND THAT THE FRONT END OF THE LUNDERQUIST WIRE GUIDE WAS RELEASING PATIENT OUTCOME: N/A - THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6696365 ↗MalfunctionJun 23, 2016Metal Shedding Debris; Component Missing
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: ''HAD A PROBLEM TODAY WITH TWO LUNDERQUIST WIRES LOSING THEIR COATING IN PATCHES. THEY WERE NEVER PASSED THROUGH ANYTHING SHARP LIKE A NEEDLE AND THE SCRUB NURSE SAYS THEY WERE FINE WHEN FLUSHED AND LOADED THROUGH THE PIGTAIL, BUT WHEN THEY WERE REMOVED FROM THE PATIENT IT WAS NOTICED THAT THERE WERE PATCHES THAT WERE BARE METAL, ONE WIRE HAS SEVERAL PATCHES ALL THE WAY ALONG THE WIRE AND THE OTHER WIRE HAS A PATCH ABOUT AN INCH LONG WHICH IS BARE METAL.'' DESCRIPTION OF EVENT ACCORDING TO ADVERSE INCIDENT REPORT: "GUIDE WIRE SHOULD HAVE COATING ALL ALONG ITS LENGTH, 2 WIRES WERE USED IN A CASE AND WERE INSPECTED ON OPENING AND FINE, BUT ON REMOVAL FROM PATIENT ONE HAD A ONE INCH SECTION WHICH WAS BARE METAL WITHOUT COATING AND THE SECOND HAD MULTIPLE PATCHES ALONG ITS LENGTH WHICH WERE MISSING THE COATING." PATIENT OUTCOME: THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE EVENTS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5743942 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.