TAIGA TA6EBU35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994830111), received between Oct 11, 2017 and Oct 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083422); they may or may not involve this specific model.

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

• MalfunctionOct 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A TAIGA GUIDE CATHETER. A RADIAL APPROACH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS EXPERIENCED WITH THE SHEATH TIP WHEN ADVANCING THE DEVICE DUE TO A SPASM IN THE BLOOD VESSEL. THE CATHETER WAS ADVANCED FURTHER WHILE BEING SLIGHTLY DISTORTED THE DISTORTION OF THE DEVICE WAS DUE TO THE RESISTANCE. EXCESSIVE FORCE WAS NOT USED. IT IS INDICATED THAT THE ORGANIC STENOSIS SITE DEVELOPED AS A RESULT OF THE BLOOD VESSEL SPASM AND ARTERIOSCLEROSIS. IT IS REPORTED THAT DURING AN ENGAGEMENT ATTEMPT THE DISTAL TIP OF THE DEVICE SEEMED TO BE TORN APART UNDER FLUOROSCOPY. WHEN WITHDRAWING THE DEVICE, THE PHYSICIAN NOTED THAT THE TIP WAS TORN APART AND BROKEN OFF. THE FRAGMENT WAS INSIDE THE TIP OF THE NON-MEDTRONIC SHEATH AND WAS REMOVED BY SLOWLY WITHDRAWING THE SHEATH. THE PROCEDURE WAS COMPLETED UNDER ANAESTHETIC, DUE TO THE PATIENT SPASM AND THE PROCEDURAL APPROACH CHANGED TO THE INGUINAL REGION. THE DETACHED PORTION OF THE DEVICE WAS REMOVED FROM THE PATIENT BEFORE THE INGUINAL REGION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6940590 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083422. One submission often covers many models, so check the product and lot details in each record.

• Z-1207-2018 · Sep 26, 2017 · Terminated
  6F Taiga Guiding Catheter