Advance G52260Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002522609), received between Jul 12, 2017 and Apr 12, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF A LESION WITHIN THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. A COOK SHEATH WAS USED DURING THE PROCEDURE. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME TO NOMINAL PRESSURE, FOR THIRTY SECONDS; HOWEVER, THE BALLOON RUPTURED LONGITUDINALLY. THE ANATOMY WAS CALCIFIED, AND THE LESION WAS 100% OCCLUDED. BLOOD WAS NOTED WITHIN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS PULLED BACK INTO THE SHEATH, OVER THE WIRE GUIDE, AND REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT BALLOON. DURING THE SAME PROCEDURE, ANOTHER COOK BALLOON RUPTURED. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19097688 ↗
• MalfunctionMar 27, 2023Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16621905 ↗
• MalfunctionAug 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, PRIOR TO USE DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LEAKED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15295400 ↗
• MalfunctionJan 10, 2020Material 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 9574670 ↗
• MalfunctionJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS PUNCTURED DURING THE FIRST INFLATION. AN UNKNOWN 6FR SHEATH AND UNKNOWN WIRE GUIDES WERE USED ALONG WITH A COOK INFLATION DEVICE. THE BALLOON WAS REMOVED BY ITSELF AFTER RUPTURING AT NOMINAL PRESSURE. REPORTEDLY, THE BALLOON WAS NOT INFLATED INSIDE OF A STENT PRIOR TO THE RUPTURE. 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 Consequences Or Impact To Patient

  MAUDE report 9537796 ↗
• MalfunctionOct 5, 2018Fracture; Fracture

  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 7938822 ↗
• MalfunctionJun 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN ANTEGRADE RIGHT FEMORAL ANGIOPLASTY PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BALLOON CATHETER. THE PATIENT'S ANATOMY WAS NEITHER TORTUOUS NOR CALCIFIED. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639021 ↗
• MalfunctionOct 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN SFA PERIPHERAL PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER COOK DEVICE. THE PATIENT'S ARTERY WAS REPORTED TO BE HEAVILY CALCIFIED. 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 6982304 ↗
• MalfunctionJul 17, 2017Positioning Problem

  IT WAS REPORTED THAT CROSSOVER TECHNIQUE WAS PERFORMED AFTER MULTIPLE STENOSES IN THE RIGHT SFA (SUPERFICIAL FEMORAL ARTERY). THERE WASN'T MUCH VESSEL CALCIFICATION, BUT THE PHYSICIAN ATTEMPTED TO DILATE THE STENOSIS TWICE AT 8 ATM. THE BALLOON RUPTURED IN THE PROXIMALE STENOSIS AT 2 ATM AFTER THE THIRD ATTEMPT. THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WAS SUCCESSFUL AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719735 ↗
• MalfunctionJul 12, 2017Material Rupture

  DURING PERCUTANEOUS ANGIOPLASTY OF AN ARTERIO-VENUS FISTULA, THE BALLOON RUPTURED AT 15 BAR. IT WAS NOTED THAT THE RUPTURE WAS LONGITUDINALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708704 ↗
• MalfunctionJul 12, 2017Material Rupture

  THE INFORMATION RECEIVED INDICATED THAT A PERCUTANEOUS ANGIOPLASTY BALLOON BURST DURING POST-DILATION A STENT. THE DEVICE WAS ADVANCED VIA CONTRALATERAL APPROACH FROM THE FEMORAL ARTERY. A GUIDE WIRE WAS ADVANCED TO THE SITE AND THE LESION WAS PRE-DILATED SEVERAL TIMES PRIOR TO STENT PLACEMENT. IT IS UNKNOWN IF THE SAME BALLOON WAS USED FOR THE SAME PRE-DILATIONS. AFTER PLACING THE STENT THE PHYSICIAN ATTEMPTED TO PERFORM POST-DILATION WITH THE PRE-DILATION BALLOON AND NOTICED THAT THE BALLOON HAD ALREADY RUPTURED. THE POST-DILATION BALLOON WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708681 ↗