Flexor G48188Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002481886), received between Jun 13, 2019 and Apr 10, 2020 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 10, 2020Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 09APR2020. DURING AN ARTERIOGRAM, THE COMPLAINT DEVICE SPLIT WHEN 'ABLATING THE EQUIPMENT'. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948174 ↗
• InjuryJun 13, 2019Material Separation; Unraveled Material; Material Separation; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED ON 08JUL2019 NOTING THE FOLLOWING: "IF THE PIECE YOU ARE LOOKING FOR IS NOT IN THE PICTURES, I CAN ONLY ASSUME IT WAS REMOVED AND DISPOSED OF." ADDITIONALLY, IT WAS PROVIDED BY THE CUSTOMER REPRESENTATIVE INITIALLY THAT "THE 4X90 ANSEL WAS NOT ABLE TO BE REMOVED AND THE OUTER COVERING STARTED TO UNRAVEL NECESSITATING A TRIP TO THE OR FOR SURGICAL REMOVAL; IT WAS REMOVED IN ITS ENTIRETY."

  Patient problems: No Code Available

  MAUDE report 8695633 ↗