GUIDELINER IPN922787Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156109127), received between Dec 9, 2024 and Jan 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Difficult to Remove; Material Separation; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DURING A CORONARY ANGIOGRAM. GUIDE LINER DISTAL SECTION AFTER THE HALF PIPE SECTION BROKEN AND APPEARS SQUASHED, PINCHED AND DIAMETER COMPROMISED. GUIDE LINER INSERTED INTO A 6FR GUIDING CATHETER AND GOT STUCK AND HAD TO BE FORCEFULLY PULLED OUT TO BE REMOVED. IT CAME OUT IN 2 PARTS, DUE TO GETTING STUCK AND FORCE USED TO PULL OUT. THE SEPARATION WAS JUST PAST THE HALFPIPE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065004 ↗
• InjuryDec 9, 2024Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT: "WIRE AND GUIDELINER INTERACTION STRIPPING GUIDELINER MATERIAL. GUIDELINER WAS UNABLE TO BE REMOVED FULLY, BUT A CORONARY WIRE REMAINED IN SITU. AT THE END OF THE CASE THE 0.035 WAS NOT ADVANCED ON GUIDE REMOVAL DUE TO THE TRICK OF DISLODGING THE GUIDELINER REMNANT INTO THE AORTA. THEREFORE THE STENT WAS BROUGHT BACK AS IT FELT AS THOUGH IT WAS CATCHING ON SOMETHING WITHIN THE EXTENSION CATHETER. ON BRINGING BOTH THE GUIDE LINER AND THE STENT BACK THE STENT WAS NOT ABLE TO BE RETRIEVED SMOOTHLY AND FIRM TENSION WAS REQUIRED TO BRING THE STENT OUT OF THE GUIDE. ON REMOVAL OF THE STENT IT WAS EVIDENT THAT A PIECE OF THE PROXIMAL END OF THE GUIDELINER WAS CAUGHT TO THE STENT ". ADDITIONAL INFORMATION: "I WAS NOT ABLE TO WIRE THROUGH THE DISSECTION APPROPRIATELY WITH A MICROCATHETER AND WIRE. I THEREFORE HAD TO TURN MY ATTENTION BACK TO THE RADIAL APPROACH AND TENTATIVELY DEPLOY A STENT DOWN THE ARTERY THROUGH THE PROXIMAL DISSECTION PLANES. THIS THEN ALLOWED ME TO APPROACH VIA THE FEMORAL APPROACH THROUGH THE TRUE LUMEN. ONCE THIS WAS SUCCESSFUL , I WAS ABLE TO DEPLOY FURTHER STENTS BUT I WAS CLEARLY LIMITED BECAUSE OF STENTING THE PROXIMAL LESION AS OPPOSED TO M

  Patient problems: Pain

  MAUDE report 20877727 ↗