Advance G52255Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522555), received between Jul 20, 2017 and Mar 27, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION. THE PATIENT'S ANATOMY WAS DESCRIBED AS SLIGHTLY CALCIFIED WITHOUT TORTUOSITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457444 ↗
• MalfunctionJul 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST CIRCUMFERENTIALLY. DURING AN UNSPECIFIED BELOW-THE-KNEE PROCEDURE, THE PHYSICIAN INFLATED THE COMPLAINT DEVICE TO NOMINAL PRESSURE USING A CONTRAST /SALINE MIXTURE. THERE WAS NO ANGULATION OF THE UNSPECIFIED VESSEL; HOWEVER, HEAVY CALCIFICATION WAS PRESENT. THE COMPLAINT DEVICE REPORTEDLY RUPTURED IMMEDIATELY AFTER INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER COOK BALLOON WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722169 ↗
• MalfunctionJan 16, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS OBSERVED TO BE BROKEN. THE DEVICE DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7195959 ↗
• MalfunctionJul 20, 2017Leak/Splash; Material Rupture

  THE COMPLAINANT REPORTED THAT THE PATIENT HAD A CALCIFIED STENOSIS AND THEY INFLATED THE BALLOON MANUALLY (MAYBE 4 ATM ACCORDING TO THE DOCTOR). THE BALLOON RUPTURED AS A RESULT OF THE INFLATION AND ANOTHER LOW PROFILE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. FURTHER EXAMINATION OF THE DEVICE NOTED A LEAK IN THE BALLOON. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727498 ↗