Advance G35536Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002355368), received between Jul 13, 2017 and Aug 2, 2019 — classified as 9 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2019Material Puncture/Hole; Material Puncture/Hole

  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 8854868 ↗
• MalfunctionMay 24, 2019Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  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 8639936 ↗
• MalfunctionJan 31, 2019Material Rupture; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Material Rupture; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  INFORMATION WAS RECEIVED (B)(6) 2019 CLARIFYING THE EVENT. IT WAS INITIALLY REPORTED THAT TWO SEPARATE PTA DEVICES WERE USED IN TWO SEPARATE PROCEDURES. HOWEVER, THE COOK AREA REPRESENTATIVE HAS SINCE CORRECTED THESE EVENTS. IN THE FIRST CASE (REPORTED IN 1820334-2019-00239), THE PTA RUPTURE IS ACCURATE. HOWEVER, THE SECOND COMPLAINT HAS BEEN UPDATED TO REFLECT A DIFFICULT ADVANCEMENT/INSERTION OF THE SECOND PTA DEVICE INTO A 5FR COOK SHEATH (THIS REPORT). THE 5FR SHEATH WAS NOT RETURNED, ONLY THE SECOND PTA DEVICE THAT WOULD NOT ADVANCE. IT SHOULD BE NOTED, THE PTA DEVICE IS COMPATIBLE WITH A 6FR SHEATH. THIS EVENT IS NO LONGER REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY , OR PRODUCT MALFUNCTION. THERE IS NO PRECEDENCE OF THIS MALFUNCTION LEADING TO AN ADVERSE EVENT. NO ADDITIONAL FOLLOW-UP REPORTS WILL BE SUBMITTED UNDER REPORT REFERENCE NUMBER 1820334-2019-00238.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293626 ↗
• MalfunctionJan 31, 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 8293625 ↗
• MalfunctionDec 4, 2018Sharp Edges; Sharp Edges

  IT WAS REPORTED, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS FOUND TO BE KINKED IN THE MID-PART OF THE DEVICE WHILE STILL IN THE PACKAGE. SHARP EDGES WERE OBSERVED. ANOTHER BRAND OF BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE ANGIOPLASTY WITH STENTING PROCEDURE. THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129286 ↗
• MalfunctionAug 27, 2018Material Perforation; Material Perforation

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7819965 ↗
• MalfunctionDec 13, 2017Hole In Material; Hole In Material

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7112985 ↗
• MalfunctionNov 20, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY STENT AND ANGIOPLASTY FOR A SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED INSIDE OF THE STENT WITHOUT ANY ANGULATION. IT WAS NOTED THAT THE BALLOON CATHETER WAS UNABLE TO HOLD PRESSURE, AND COULD NOT GET TO EIGHT (8) PSI. CONTRAST UTILIZED WAS A MIX OF 5 CUBIC CENTIMETER (CC) VISIPAQUE TO 15 CC OF HEX SALINE; THE PATIENT WAS REPORTED TO HAVE HIGHLY CALCIFIED VESSELS. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS REMOVED, REPLACED WITH ANOTHER COOK MEDICAL BALLOON CATHETER, AND THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. 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 7046764 ↗
• MalfunctionJul 13, 2017Fluid/Blood Leak

  IT WAS NOTED THAT THERE IS A PINHOLE SIZE LEAK IN THE BALLOON. THERE WERE NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6709901 ↗