Advance G52268Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522685), received between Aug 23, 2018 and Dec 30, 2021 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. THE BALLOON DEVICE WAS SUCCESSFULLY WITHDRAWN FROM THE SHEATH ASSOCIATED WITH REPORT WITH MDR #: 1820334-2021-02754. WHEN ASKED IF THE BALLOON CATHETER OR BALLOON MATERIAL SEPARATED, THE CUSTOMER REPLIED WITH "THE SHEATH SEPARATED". ADDITIONALLY, A PHOTO PROVIDED BY THE CUSTOMER DOES NOT SHOW ANY SEPARATION OF THE BALLOON OR BALLOON CATHETER MATERIAL ASSOCIATED WITH THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13118160 ↗
• MalfunctionMar 14, 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 8422266 ↗
• MalfunctionAug 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, PRIOR TO A STENT PLACEMENT, A PRE-DILATATION OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY WAS PERFORMED USING "DIFFERENT BALLOONS." DURING PREDILATATION, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS PLACED, AND INFLATED TO 9 ATMOSPHERES WHEN IT RUPTURED. THE COMPLAINT DEVICE WAS RETURNED TO AMBIENT PRESSURE AND REMOVED, BUT NOT UTILIZING A CLOCKWISE ROTATION. THE COMPLAINT DEVICE WAS THEN REPLACED WITH ANOTHER BALLOON AND THE PROCEDURE WAS COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERY. THE VESSEL WAS MODERATELY CALCIFIED BUT NOT ANGULATED. A MIXTURE OF ULTRAVIST CONTRAST AND SALINE WAS UTILIZED IN A 1:1 RATIO. OTHER DEVICES USED INCLUDE A 6FR (FRENCH) SHEATH AND A WIRE GUIDE, WHICH WERE IN PLACE DURING REMOVAL. A SECOND PRE-DILATATION PROCEDURE WAS PERFORMED PRIOR TO THE PLACEMENT OF THE STENT, HOWEVER IT WAS NOT MADE CLEAR TO THE COMPLAINANT IF THIS PROCEDURE WAS PART OF THE COURSE OF EVENTS LEADING TO STENT PLACEMENT, OR IF IT WAS A RESULT OF THE RUPTURE OF THE COMPLAINT DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809923 ↗