TAIGA TA6JR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994828743), received between Oct 26, 2017 and Oct 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 26, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS USING A TAIGA GUIDE CATHETER WHEN TREATING THE RCA. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. THE TAIGA WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE TAIGA HAD BEEN INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. IT IS REPORTED THAT WHEN THE DEVICE WAS INSERTED VIA THE TRANSRADIAL APPROACH FOR PCI, THE DEVICE ENCOUNTERED RESISTANCE IN THE BRACHIAL ARTERY. WHEN THE DEVICE WAS REMOVED OUT OF THE PATIENT¿S BODY AND CHECKED, A TEAR WAS NOTED AT THE SOFT TIP OF THE DEVICE. THEREFORE THE CUSTOMER DISCONTINUED USING THE DEVICE AND COMPLETED THE PROCEDURE WITH A NON-MDT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6979975 ↗

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