Flexor G30003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002300033), received between May 15, 2017 and May 17, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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.

• MalfunctionMay 17, 2017Stretched; Failure to Advance

  IT WAS REPORTED THE COMPLAINT DEVICE WAS USED TO TREAT THE LESION IN PROXIMAL PART OF LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ANGLE OF THE ILIAC BIFURCATION WAS SEVERE. THE RIGHT FEMORAL ARTERY WAS PUNCTURED AND ANSEL SHEATH WAS ADVANCED BY CONTRALATERAL APPROACH. HOWEVER, THE SHEATH WOULD NOT PASS THROUGH THE AORTIC BIFURCATION. THUS, THE PHYSICIAN GAVE UP CONTRALATERAL APPROACH WITH ANSEL SHEATH, AND THE PROCEDURE WAS COMPLETED BY IPSILATERAL APPROACH WITH ANOTHER MANUFACTURER'S SHEATH. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS OF THE PHYSICIANS OPINION THAT CAUSE OF THE EVENT WAS THE SEVERE ANGLE OF THE BIFURCATION AND CALCIFICATION IN THE ACCESS ROUTE AND INFLEXIBILITY OF THE ARTERY. PER IMAGES OF THE RETURNED PRODUCT THE SHEATH TIP WAS STRETCHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572055 ↗
• MalfunctionMay 15, 2017Break; Stretched; Failure to Advance; Torn Material

  THE DEVICE WAS USED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE LEFT SUBCLAVIAN ARTERY, INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY (CFA), BUT IT WOULD NOT ADVANCE. THE USER REMOVED THE DEVICE ONCE TO CHECK IT AND FOUND THAT THE TIP WAS DAMAGED. THEN, DILATION WAS PERFORMED WITH A 5FR SHEATH AND ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD. THE PHYSICIAN COMMENTED THE PUNCTURE SITE WAS A BIT HARD. EXAMINATION OF THE DEVICE REVEALED A SMALL TEAR AND STRETCHING NOTICED AT THE TIP. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567871 ↗