Advance G52373Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002523736), received between Jul 17, 2017 and May 23, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionMay 23, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988747 ↗
• InjuryApr 29, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 11744177 ↗
• MalfunctionMar 22, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542246 ↗
• InjuryJul 1, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE RADIOPAQUE MARKER SEPARATED FROM AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. THE SEPARATED PORTION OF THE DEVICE REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 10218770 ↗
• InjurySep 13, 2019Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019. AS REPORTED, THE ADDITIONAL SMALL INCISION MADE WAS AN ENLARGEMENT OF THE ORIGINAL ACCESS SITE.

  Patient problems: No Code Available

  MAUDE report 9035856 ↗
• InjuryFeb 8, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  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 8322244 ↗
• MalfunctionJul 17, 2017Break; Kinked; Sticking; Material Twisted/Bent; Torn Material

  THE LOW PROFILE BALLOON CATHETER WAS USED FOR PPI (PERCUTANEOUS PERIPHERAL INTERVENTION) ON A PATIENT WITH STENOSIS IN THE LEFT CIA (COMMON ILIAC ARTERY). THE STENOSIS WAS FOR 5CM IN LENGTH FROM THE CIA BIFURCATION. ANOTHER MANUFACTURER'S 6 FR SHEATH WAS USED TOGETHER WITH THE DEVICE. THE DEVICE WAS INSERTED OVER A 0.018INCH WIRE GUIDE INTO THE SHEATH BY IPSILATERAL APPROACH. DURING ADVANCEMENT, THE DEVICE GOT STUCK INSIDE THE SHEATH AND COULD NOT REACH TO THE LESION. THEN, THE WIRE GUIDE WAS CHANGED WITH 0.035INCH WIRE GUIDE TO AID THE DEVICE ADVANCEMENT TO THE LESION. HOWEVER, THE DEVICES WERE REMOVED BECAUSE THE LOW PROFILE BALLOON CATHETER WAS STILL STUCK. SINCE A KINK IN THE SHAFT WAS VISUALLY OBSERVED, THE PHYSICIAN STOPPED USING THE DEVICE. IT WAS FURTHER NOTED THAT THE CATHETER HAD A "DAMAGED/TWISTED MOTION NEAR THE BALLOON" WITH A TEAR IN THE CATHETER OF THE PTA BALLOON. ANOTHER LOW PROFILE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719691 ↗