GUIDELINER IPN913565Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156100575), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionOct 15, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: DURING A PCI PLUS STENTING, A PIECE OF THE GUIDELINER V3 BROKE OFF, HOWEVER, FOUND AND SAVED. BROKEN PART IS IN A LITTLE CONTAINER. DEVICE PROFESSIONAL ALLEGES THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. NO MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RECEIVE ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. PORTED: DURING A PCI PLUS STENTING, A PIECE OF THE GUIDELINER V3 BROKE OFF, HOWEVER, FOUND AND SAVED. BROKEN PART IS IN A LITTLE CONTAINER. DEVICE PROFESSIONAL ALLEGES THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. NO MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RECEIVE ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10684817 ↗