Advance G30964Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002309644), received between Mar 30, 2017 and Aug 27, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WITHIN CHRONIC TOTAL OCCLUSIONS OF THE LEFT SUPERFICIAL FEMORAL AND LEFT POSTERIOR TIBIAL ARTERIES, TWO ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS¿ BALLOONS RUPTURED. ACCESS WAS OBTAINED IN THE LEFT POSTERIOR TIBIAL ARTERY. PER THE REPORTER, A PRE-EXISTING STENT CAUSED THE BALLOONS TO RUPTURE. AN UNSPECIFIED ¿1.5 LASER¿ WAS USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER, WIRE GUIDES, AND STENT. REPORTEDLY, ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER¿S BALLOON FROM A DIFFERENT LOT ALSO RUPTURED DURING THE PROCEDURE. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, AND AN 8X80 STENT WAS PLACED. 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 20078889 ↗
• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WITHIN CHRONIC TOTAL OCCLUSIONS OF THE LEFT SUPERFICIAL FEMORAL AND LEFT POSTERIOR TIBIAL ARTERIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER¿S BALLOON RUPTURED. ACCESS WAS OBTAINED IN THE LEFT POSTERIOR TIBIAL ARTERY. PER THE REPORTER, A PRE-EXISTING STENT CAUSED THE BALLOON TO RUPTURE. AN UNSPECIFIED ¿1.5 LASER¿ WAS USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER, WIRE GUIDES, AND STENT. REPORTEDLY, TWO OTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS¿ BALLOONS FROM A DIFFERENT LOT ALSO RUPTURED DURING THE PROCEDURE. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, AND AN 8X80 STENT WAS PLACED. 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 20078862 ↗
• InjuryJul 21, 2023Break; Difficult to Remove; Break; Difficult to Remove

  AS REPORTED, DURING A PROCEDURE INVOLVING DILATION OF A PRE-THROMBOTIC, STENOSED BRACHIO-BRACHIAL ARTERIOVENOUS FISTULA IN THE LEFT ARM, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER SEPARATED. AN UNKNOWN SHEATH AND WIRE WERE USED DURING THE PROCEDURE. AFTER DILATION OF THE RESISTANT STENOSIS, THE COMPLAINT DEVICE REPORTEDLY BECAME STUCK IN THE PATIENT. THE BALLOON AND CATHETER THEN SEPARATED AS THE PHYSICIAN PULLED ON THE DEVICE. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED FRAGMENT ,USING TWO "LASSOS"; HOWEVER, THE DEVICE WAS UNABLE TO BE RETRIEVED, LEAVING APPROXIMATELY TEN CENTIMETERS OF THE DEVICE IN THE PATIENT'S ARM. THE FISTULA THROMBOSED, AND PER THE USER, SINCE BLOOD IS NO LONGER CIRCULATING THROUGH THE FISTULA, THE SEPARATED FRAGMENT WILL NOT MIGRATE. A DIALYSIS CATHETER WAS PLACED ON THE RIGHT SIDE TO CARE FOR THE PATIENT. IT HAS ALSO BEEN REPORTED THAT A NEW FISTULA WAS CREATED IN THE RIGHT ARM. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 17371704 ↗
• MalfunctionMar 15, 2023Break; Material Rupture; Break; Material Rupture

  ADDITIONAL INFORMATION RECEIVED 17MAR2023. THE PRESSURE RATE IS UNKNOWN, BUT IT WAS NOT TAKEN TO "BURST PRESSURE". THE DEVICE WAS NOT TAKEN OUT AND PUT BACK IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547002 ↗
• MalfunctionJan 20, 2021Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED 20JAN2021 AND INCIDENTALLY OMITTED FROM THE INITIAL MDR. ONCE THE BALLOON WAS DEFLATED, THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE. NEGATIVE PRESSURE WAS MAINTAINED DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11201796 ↗
• MalfunctionSep 14, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING A SUPERFICIAL FEMORAL AND TIBIAL ATHERECTOMY PROCEDURE WITH STENT PLACEMENT, INVOLVING A PATIENT IS HIS SEVENTIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS OBTAINED IN THE TIBIAL VESSEL VIA THE ANKLE. THE VESSELS WERE REPORTEDLY EXTREMELY CALCIFIED. THE COMPLAINT BALLOON WAS USED; HOWEVER THAT DEVICE RUPTURED CIRCUMFERENTIALLY. ANOTHER COOK BALLOON WAS THEN INSERTED VIA GROIN ACCESS TO PREVENT BLEEDING. THAT BALLOON REPORTEDLY BECAME MANGLED AND SEPARATED. THE SECOND BALLOON WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). REPORTEDLY, THE TIBIAL ARTERY WAS TIED OFF DURING THE PROCEDURE. THE PHYSICIAN SPECULATED THAT CALCIFICATION WAS A CONTRIBUTING FACTOR. 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, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529185 ↗
• MalfunctionMar 19, 2020Material 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 9854007 ↗
• MalfunctionNov 15, 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 9329533 ↗
• MalfunctionApr 9, 2019Deflation Problem; Deflation Problem

  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 8497301 ↗
• MalfunctionFeb 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, A (B)(6) MALE WAS UNDERGOING AN INTERVENTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY FROM THE RIGHT GROIN. THE PATIENT'S VASCULATURE WAS DESCRIBED AS SEVERELY CALCIFIED BUT NOT TORTUOUS OR ANGLED. THE PHYSICIAN INFLATED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER FOR 30 SECONDS AND DEFLATED ONCE USING A 70/30 MIXTURE OF OMNIPAQUE 350 CONTRAST TO SALINE. THE PHYSICIAN MOVED THE COMPLAINT BALLOON TO AN UNSPECIFIED AREA AND ATTEMPTED A SECOND INFLATION. IT WAS NOTED THE BALLOON WOULD NOT FULLY INFLATE. INFLATION PRESSURE WAS REPORTED TO BE 8 ATMOSPHERES (ATM). THE PHYSICIAN DEFLATED THE BALLOON AND NOTICED BLOOD IN THE COOK INFLATION DEVICE. IT WAS SUBSEQUENTLY DETERMINED THE BALLOON RUPTURED AND IT WAS REMOVED THROUGH THE ANSEL SHEATH. ANOTHER MANUFACTURER'S .018 GUIDE WIRE WAS OVER THE BALLOON. THE PATIENT WAS NOT HARMED AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. NO PORTION OF THE BALLOON REMAINED IN THE PATIENT'S ANATOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358149 ↗
• MalfunctionMay 29, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS INFLATED TO 8 ATMOSPHERES (ATM) AND BURST LONGITUDINALLY INSIDE THE PATIENT'S ANATOMY. REPORTEDLY, THE BALLOON WOULD NOT DEFLATE AND THE PATIENT'S ANATOMY WAS DESCRIBED AS "TORTUOUS". AFTER SUCCESSFUL REMOVAL OVER THE WIRE GUIDE, IT WAS OBSERVED THE BALLOON RESEMBLED A "LONG FILAMENT, OR LIKE A YARN". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S ANATOMY NOR WERE ANY ADDITIONAL PROCEDURES REQUIRED. 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 7549383 ↗
• MalfunctionDec 13, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR A SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AT AN INFLATION PRESSURE OF 10 ATMOSPHERE (ATM). THE BALLOON CATHETER WAS REMOVED, AND ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S VESSELS WERE NOTED TO BE CALCIFIED. 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 7114825 ↗
• MalfunctionMar 30, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION/DILATION, WHILE USING AN ADVANCE 18 LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED (CIRCUMFERENTIALLY) WHILE BEING INFLATED. IT WAS REPORTED THAT ALTHOUGH THERE WAS NO ANGULATION, THERE WAS HEAVY CALCIFICATION OF THE VESSEL. AT THE TIME THE BALLOON WAS BEING WITHDRAWN, THERE WAS VERY LITTLE RESISTANCE AND IT WAS NOTED TO BE IN 2 PIECES. THE PATIENT UNDERWENT AN ADDITIONAL ANGIOPLASTY PROCEDURE USING A COOK 6X100 BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446203 ↗