Lunderquist G45353Recalls & reported problems
William Cook Europe ApS · Lunderquist, Extra Stiff Wire Guide · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002453531), received between May 12, 2016 and Nov 27, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Flaked2
- Peeled/Delaminated2
- Device Damaged by Another Device1
- Difficult to Remove1
- Noise, Audible1
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJul 1, 2020Flaked; Flaked
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10216379 ↗MalfunctionDec 17, 2018Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8168432 ↗MalfunctionApr 20, 2017Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DOCTOR FELT THE WIRE GUIDE GOT CAUGHT ON THE STENT GRAFT AND MADE A BURR ON THE WIRE AND THE WIRE THEN GOT CAUGHT IN THE CATHETER LUMEN. WHEN HE TRIED TO REMOVE THE WIRE IT UNRAVELLED IN THE CATHETER. HE WAS ABLE TO REMOVE IT SAFELY FROM THE PATIENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6506543 ↗MalfunctionMay 12, 2016Peeled/Delaminated; Device Damaged by Another Device; Noise, Audible; Peeled/Delaminated; Device Damaged by Another Device
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE COATING WAS COMING OFF FROM THE WIRE AND A METAL SOUND WAS HEARD. PATIENT OUTCOME: ADDITIONAL INFORMATION HAS YET TO BE PROVIDED BY THE REPORTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5649623 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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.