Advance G52379Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002523798), received between Sep 13, 2017 and Nov 16, 2018 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2018Material Rupture; Material Rupture

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

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8077569 ↗
• MalfunctionFeb 28, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING A FISTULAPLASTY FOR THE PATIENT'S ARM, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AFTER BEING INFLATED TO PRESSURE LESS THAN THE RATED BURST PRESSURE (RBP) OF 10 ATMOSPHERE (ATM) IN A VERY TIGHT STRICTURE. A MIXTURE OF CONTRAST SOLUTION AND SALINE USING AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. UPON REMOVAL OF THE BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON RUPTURED IN A CIRCUMFERENTIAL MANNER AS OPPOSED TO A LONGITUDINAL FRACTURE. THE SURGEON ENCOUNTERED DIFFICULTY IN REMOVING THE BALLOON CATHETER THROUGH THE SEVEN (7) FR SHEATH BEING UTILIZED, AND FELT AS THOUGH IT MIGHT SNAP. THE SURGEON PROCEEDED TO REMOVE THE BALLOON CATHETER, SHEATH AND WIRE GUIDE TOGETHER AS THE RUPTURED BALLOON WAS UNABLE TO BE REMOVED THROUGH THE SHEATH. 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 7302877 ↗
• InjuryDec 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PRE-DILATION FOR AORTIC STENOSIS TREATMENT, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY IN THE PATIENT'S GROIN. A PIECE OF THE TORN BALLOON DISLOCATED IN THE PATIENT'S GROIN AND WAS ATTEMPTED TO BE SURGICALLY REMOVED UNDER GENERAL ANESTHESIA AND INTUBATION. THE BALLOON PIECE THEN DISLOCATED INTO THE PATIENT'S FEMORAL ARTERY, AND BECAME STUCK DUE TO A PRE-EXISTING OCCLUSION. THE PHYSICIAN DID NOT ATTEMPT FURTHER RECOVERY OF THE BALLOON PIECE. THE AORTIC STENOSIS TREATMENT WAS ABLE TO BE SUCCESSFULLY COMPLETED. A SIX (6) FR SHEATH WAS UTILIZED; THE PATIENT'S VESSELS WERE REPORTED TO BE CALCIFIED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7140639 ↗
• InjurySep 13, 2017Material Separation; Material Separation

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, DURING INFLATION OF A STENT, THE BALLOON SEPARATED FROM THE SHAFT. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON; HOWEVER, IT WAS UNABLE TO BE VISUALIZED DURING A SCREENING OF THE AREA. THE BALLOON WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6862592 ↗