Lunderquist G45208Recalls & reported problems
William Cook Europe ApS · Lunderquist, Extra Stiff DC Wire Guide · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002452084), received between Sep 12, 2016 and Mar 12, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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
- Material Too Rigid or Stiff2
- Inadequacy of Device Shape and/or Size1
- Scratched Material1
- Unraveled Material1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗InjurySep 2, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
ACCORDING TO INITIAL REPORTER: WHEN ADVANCING LUNDERQUIST(R) EXTRA-STIFF WIRE GUIDE, THE CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE CURLED AND PERFORATED THE ILIAC ARTERY OF THE PATIENT. A BALLOON WAS INSERTED TO TAMPONADE THE BLEEDING. VASCULAR SURGERY WAS CALLED IN FOR REPAIR OF THE ILIAC ARTERY. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12412802 ↗InjuryAug 16, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON (B)(6) 2021: ACCORDING TO THE MEDICAL RECORD, THIS WAS AN 85 YEAR OLD, MALE, PATIENT, 49.1 KG. THERE IS NOTHING IN THE MEDICAL RECORD TO SUGGEST A RETAINED BODY FOLLOWING VASCULAR SURGERY. ACCORDING TO THE MEDICAL RECORD, THE PATIENT WAS ADMITTED FOR 7 DAYS. NO PHOTOS OR VIDEO CAN BE PROVIDED ACCORDING TO THE MEDICAL RECORD, ACCESS WAS ACHIEVED VIA THE RIGHT COMMON FEMORAL ARTERY. ACCORDING TO THE MEDICAL RECORD, THE PATIENT HAD HYPERTENSION, HYPERCHOLESTEROLEMIA, CORONARY ARTERY DISEASE, CHRONIC KIDNEY DISEASE, SYMPTOMATIC AORTIC VALVULAR STENOSIS, MYASTHENIA GRAVIS, AND BRADYCARDIA. WHAT OTHER MEDICAL DEVICES WERE UTILIZED IN THIS CASE? THE PATIENT UNDERWENT A TRANSAORTIC VALVE REPLACEMENT. THERE WERE NUMEROUS MEDICAL DEVICES USE IN THIS CASE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12323509 ↗MalfunctionFeb 13, 2018Unraveled Material; Unraveled Material
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "I HAVE A LUNDERQUIST WIRE THAT ESSENTIALLY CAME APART AND UNRAVELED DURING A PROCEDURE." PATIENT OUTCOME: UNKNOWN.
Patient problems: No Information
MAUDE report 7265844 ↗MalfunctionSep 12, 2016Scratched Material; Scratched Material
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THEY FLUSH SYSTEM AND INTRODUCERS THEY FIND SMALL PIECES OF THE LUNDERQUIST ON THE COMPRESS. AND YOU CAN SEE ON THE LUNDERQUIST THAT SOME OF THE TEFLON IS MISSING. WHEN THEY FLUSH DELIVERY SYSTEM AFTER PLANTED THE GRAFT, THEY SEE A LOT OF SMALL PARTICLES ON A COMPRESS. YOU CAN SEE ON THE WIRE THAT IT IS MISSING PARTS. 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 Consequences Or Impact To Patient
MAUDE report 5942358 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.