Advance G52353Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002523538), received between Nov 7, 2016 and Nov 9, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED 07NOV2023 STATING THAT AN UNSPECIFIED INFLATION DEVICE WAS USED. THE BALLOON "EXPLODED" UPON FIRST INFLATION TO APPROXIMATELY 7 ATMOSPHERES. THE PATIENT'S ANATOMY WAS NOT STENOSED, TORTIOUS, OR CALCIFIED, HOWEVER, THE ARTERIOVENOUS SHUNT WAS APPROXIMATELY 50% STENOSED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED COMPETITOR'S BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099894 ↗
• MalfunctionFeb 24, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11372687 ↗
• MalfunctionAug 12, 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 8883783 ↗
• InjuryMay 16, 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 Code Available

  MAUDE report 8616521 ↗
• MalfunctionOct 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN ANGIOPLASTY OF A FISTULA, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WOULD NOT HOLD CONTRAST WHICH WAS A 50/50 MIXTURE OF VISIPAQUE AND SALINE. IT COULD BE SEEN LEAKING OUT UNDER X-RAY. THE BALLOON WAS NEVER INFLATED. THE COMPLAINT DEVICE WAS REMOVED AND ANOTHER OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PATIENT OUTCOME WAS REPORTED AS GOOD. PER THE COMPLAINANT THE COMPLAINT DEVICE WAS PROBABLY BROKEN UPON ENTRY. THE PATIENT'S ANATOMY WAS NOT CALCIFIED. 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 7993737 ↗
• MalfunctionJul 26, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED AS A PHYSICIAN WAS ATTEMPTING TO PLACE A STENT IN A DIALYSIS FISTULA LOCATED IN THE PATIENT'S RIGHT ARM WHEN THE BALLOON RUPTURED CIRCUMFERENTIALLY DURING INFLATION OF THE BALLOON. IT WAS REPORTED THAT A 50/50 MIXTURE OF SALINE AND ISOVIEW WAS USED DURING THE PROCEDURE, AND THE INFLATION PRESSURE IS UNKNOWN. IT WAS ALSO REPORTED THAT THERE WAS SLIGHT ANGULATION INSIDE OF THE VESSEL BUT NO CALCIFICATION. THERE WAS NO PART OF THE DEVICE LEFT IN THE PATIENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745479 ↗
• InjuryNov 7, 2016Burst Container or Vessel; Burst Container or Vessel

  THE BALLOON RUPTURED CIRCUMFERENTIALLY. UPON PULLING THE BALLOON OUT, PIECES OF THE BALLOON WERE LEFT INSIDE THE PATIENT AND HAD TO BE REMOVED USING A SNARE. HOWEVER, ONE BALLOON MARKER HAD GONE DOWN TO PARENTERAL, AND THE USER WAS UNABLE TO RETRIEVE THIS PIECE. NOT FLOW LIMITING, THEREFORE THE PIECE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6081711 ↗