Advance G52346Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002523460), received between Feb 17, 2016 and Mar 29, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8467433 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel

  THE INFORMATION REPORTED INDICATED THAT DURING ANGIOPLASTY OF AN ARTERIOVENOUS FISTULA, THE BALLOON "BLEW UP" WHEN THEY INFLATED IT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714767 ↗
• InjuryFeb 17, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING A PTA, AXILLARY VEIN PROCEDURE ON THE FEMALE PATIENT, THE USER INFLATED THE BALLOON; HOWEVER, IT BURST AT 14 ATM. AS THE DISTAL PORTION OF THE BALLOON CATHETER RUPTURED WITHIN THE BODY OF THE PATIENT; A SNARE WAS USED TO RETRIEVE THE REMAINING PORTION. NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 5440559 ↗