GUIDELINER IPN913566Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156100582), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN ADVANCING THE STENT DELIVERY SYSTEM, THE USER FELT MUCH RESISTANCE, SO PHYSICIAN TRIED TO WITHDRAW THE STENT, BUT IT WAS UNABLE TO DO IT, THEN THE USER WITHDREW THE STENT AND THE GUIDELINER TOGETHER. THE CASE WAS COMPLETED WITH A NEW 5.5F GUIDELINER AND A NEW STENT. NO PATIENT INJURY WAS REPORTED. DURING PRELIMINARY INSPECTION OF RETURNED DEVICE ON (B)(6) 2020 IT WAS OBSERVED THAT THE RX LUMEN WAS MISSING. THE ACCOUNT WAS INQUIRED ON (B)(6) 2020 FOR FURTHER INFORMATION ON THE PROCEDURE. RESPONSE WAS RECEIVED ON (B)(6) 2020. THE VESSEL WAS TORTUOUS AND SEVERELY CALCIFIED. IT WAS NOTED THAT A WHOLE SET OF DEVICES WERE REMOVED TOGETHER FROM THE PATIENT BODY AND WAS DIFFICULT. THE RX LUMEN IS LIKELY TO HAVE GOT STUCK WITHIN THE GUIDE CATHETER DUE TO CONCOMITANT DEVICE INTERACTION WITH OTHER DEVICES SUCH AS STENT SYSTEM, GUIDEWIRE AND GUIDE CATHETER. THE ACCOUNT ALSO STATED THAT THE SEPARATION OF THE RX LUMEN DID NOT OCCUR INSIDE THE PATIENT BODY. THE SEPARATED SHAFT WAS NOT RETAINED AND DISCARDED. NO OTHER DEVICES WERE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131409 ↗