Lunderquist G46729Recalls & reported problems
William Cook Europe ApS · Lunderquist, Extra Stiff Wire Guide · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002467293), received between May 31, 2017 and Oct 21, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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-Device Incompatibility1
- Improper or Incorrect Procedure or Method1
- Unraveled Material1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMay 31, 2017Unraveled Material; Unraveled Material
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WIRE DISINTEGRATED INTO INDIVIDUAL STRANDS WHEN BEING PULLED OUT OF THE CATHETER. THE PHYSICIAN WASN´T ABLE TO PULL OUT THE GUIDE WIRE THROUGH THE CANNULA OF THE LABS-100-J SET. AFTER HE MANAGED TO PULL THE GUIDE WIRE OUT, THE WIRE WAS PARTLY BROKEN, BUT NOT TOTALLY BROKEN. 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 6600523 ↗
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.