Advance G30949Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002309491), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE OF THE POPLITEAL ARTERY INVOLVING A PATIENT WITH A HISTORY OF PERIPHERAL ARTERY DISEASE, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED. A 6 FRENCH COOK ANSEL SHEATH WAS USED AND AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME USING OMNIPAQUE CONTRAST, TO APPROXIMATELY SIX ATMOSPHERES, WHEN THE BALLOON RUPTURED AND SEPARATED. REPORTEDLY, A PRE-DILATION WITH ANOTHER MANUFACTURER'S BALLOON OCCURRED PRIOR TO USING THE COMPLAINT DEVICE. THE ANATOMY WAS REPORTED TO BE HEAVILY CALCIFIED, AND THE ABOVE-THE-KNEE POPLITEAL LESION WAS APPROXIMATELY 99% OCCLUDED. TORTUOSITY WAS NOT REPORTED. THE DEVICE WAS NOT INFLATED INSIDE A STENT PRIOR TO RUPTURE. THE DISTAL END OF THE BALLOON REMAINED IN THE PATIENT, AS THE PHYSICIAN WAS UNABLE TO REMOVE IT. THE PHYSICIAN STENTED THE BALLOON IN PLACE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9437629 ↗