Advance G52278Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522784), received between May 18, 2016 and Oct 30, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Break; Break

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON REPORTEDLY RUPTURED AFTER INFLATION "EVEN RESPECTING THE PRESSURE LIMIT, AFTER FLARE INSIDE THE STENT." THE BALLOON AND CATHETER TIP THEN SEPARATED IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570737 ↗
• InjuryJul 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE PHYSICIAN NOTED THAT THE BALLOON WOULD ONLY PARTIALLY INFLATE AND THEN WOULD NOT DEFLATE. THE SHAFT/BALLOON CATHETER WAS CUT IN AN ATTEMPT TO DEFLATE THE BALLOON AND AFTER MULTIPLE ATTEMPTS, THE BALLOON FINALLY DEFLATED. THE PRODUCT WAS REMOVED FROM THE PATIENT WITHOUT APPARENT TRAUMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719690 ↗
• MalfunctionDec 5, 2016Material Rupture; Material Rupture

  IT WAS REPORTED AFTER STENTING POST DILATATION WITH THE BALLOON CATHETER, THE BALLOON RUPTURED LONGITUDINAL AT PRESSURE 6 ATM. 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 6145564 ↗
• InjuryMay 18, 2016Material Rupture; Material Rupture

  THE BALLOON BURST AND RIPPED IN TWO PARTS AT 13 ATM WHILE DILATING. THE PARTS WERE RECOVERED WITH AN 8 FR. INTRODUCER AND SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5663926 ↗