GUIDELINER IPN931265Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156103804), received between Jan 7, 2026 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT: "DURING A PCI, DR USED A 5FR GUIDELINER TO HELP DELIVER A STENT ON A 5FR SYSTEM. THE GUIDELINER SNAPPED ON THE PROXIMAL END DISTAL TO THE COLLAR INSIDE THE 5FR GUIDE WHILE PULLING IT BACK, THERE WAS NO HARM TO THE PT, THE STENT WAS DEPLOYED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728575 ↗
• InjuryJan 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT: "WHEN INSERTING A BALLOON INTO A 5F GUIDELINER THE BALLOON DOES NOT PASS THROUGH. REMOVAL OF THE GUIDELINER REVEALS THAT IT IS DEFECTIVE AND APPEARS TO BE TORN. IMMEDIATE ACTION TAKEN: REPLACEMENT OF THE GUIDELINER. THERE WAS NO IMPACT TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987538 ↗