Advance G52341Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002523415), received between Sep 5, 2017 and Jan 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionJan 24, 2022Break; Break

  IT WAS REPORTED THAT THE BALLOON OF AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DETACHED FROM THE CATHETER WHEN REMOVING THE DEVICE FROM THE PACKAGING PRIOR TO AN UNSPECIFIED PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333061 ↗
• InjuryJan 28, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED IN A HEAVILY CALCIFIED LESION IN THE PATIENT'S LEFT COMMON ILIAC. THE COMPLAINT DEVICE HAD BEEN SUCCESSFULLY INFLATED USING A CONTRAST TO SALINE MIXTURE IN A 50:50 RATIO. IT DID NOT RUPTURE DURING INFLATION AND WAS ALLOWED TO COME TO AMBIENT PRESSURE PRIOR TO REMOVAL. IT IS NOT KNOWN IF THE DEVICE WAS BEING REMOVED WITH A CLOCKWISE ROTATION. HOWEVER, UPON REMOVAL, THE COMPLAINT DEVICE CAUGHT ON A VESSEL CALCIFICATION AND RUPTURED AND THE BALLOON PORTION SEPARATED FROM THE SHAFT OF THE CATHETER. THE PROCEDURE WAS NOT COMPLETED. THE (B)(6) FEMALE WAS TAKEN TO THE OPERATING ROOM WHERE THE RETAINED PORTION WAS REMOVED SURGICALLY. ACCORDING TO THE COOK REPRESENTATIVE NO ADDITIONAL PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION. IT WAS DISCARDED AT THE FACILITY. IMAGING HAS BEEN REQUESTED.

  Patient problems: No Code Available

  MAUDE report 8281493 ↗
• MalfunctionSep 5, 2017Inflation Problem; Inflation Problem

  TWO ADVANCE 35 LP LOW PROFILE BALLOON CATHETERS WERE USED IN THE RIGHT LEG FOR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE. IT WAS REPORTED THAT AFTER THE FIRST BALLOON WAS PLACED IT WAS UNABLE TO BE INFLATED USING AN INFLATION DEVICE. THE BALLOON WAS EXCHANGED FOR A NEW ONE, HOWEVER, THE SECOND BALLOON WAS ALSO UNABLE TO BE INFLATED. A THIRD BALLOON WAS USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ISSUE. 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 6842828 ↗