Advance G30956Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002309569), received between Jul 21, 2017 and Jul 21, 2017 — classified as 1 injury.

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

• InjuryJul 21, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING THE SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION THE BALLOON RUPTURED IN THE LESION. THE MEDICAL TEAM'S INITIAL ATTEMPTS TO REMOVE THE BALLOON WHERE UNSUCCESSFUL BECAUSE ONLY PART OF THE BALLOON WOULD RE-ENTER THE SHEATH. CONTINUED ATTEMPTS AT REMOVAL CAUSED THE BALLOON TO SEPARATE. HALF OF IT CAME OUT ON THE GUIDE WIRE, WHILE ANOTHER PIECE CAME OUT LATER ON THE OTHER END OF THE WIRE. THE PHYSICIAN HAD TO REACCESS THE SITE, BUT WAS ABLE TO SUCCESSFULLY RETRIEVE THE REMAINING PIECE WITH A SNARE. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6733714 ↗