Advance G50333Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10827002503332), received between Apr 11, 2017 and Aug 24, 2022 — classified as 16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TIBIAL ANGIOPLASTY PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LEAKED UPON THE FIRST INFLATION. THE BALLOON LEAKED AND BLOOD WAS NOTED IN THE BALLOON LUMEN. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287689 ↗
• MalfunctionFeb 10, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ADDITIONAL INFORMATION WAS PROVIDED ON 24FEB2021: A SHEATH AND INFLATION DEVICE WERE UTILIZED DURING THE PROCEDURE. THERE WAS VESSEL TORTUOSITY AND MODERATE CALCIFICATION NOTED. THE LESION WAS LOCATED AT THE DISTAL END OF THE ANTERIOR TIBIAL ARTERY AND WAS 70 PERCENT OCCLUDED. THE DEVICE WAS INFLATED TO A PRESSURE OF 8-14 ATM.

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

  MAUDE report 11306913 ↗
• MalfunctionFeb 8, 2021Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING A BELOW THE KNEE ANGIOPLASTY, THE BALLOON RUPTURED FROM A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER. A 6FR COOK ANSEL 45CM SHEATH WAS ALSO UTILIZED DURING THE PROCEDURE. THE LESION WAS LOCATED IN THE POSTERIOR TIBIA WITH 90% OCCLUDED. THE INFLATION DEVICE USED WAS FROM ANOTHER MANUFACTURER. THE BALLOON HAD BEEN INFLATED AT LEAST TWO TIMES AND THE DURATION OF THE INFLATIONS IS UNKNOWN. THE INFLATION PRESSURE WAS UNKNOWN. THERE WAS BLOOD NOTED IN THE INFLATION DEVICE. THE CONTRAST USED FOR INFLATION WAS UNKNOWN. THEY WERE ABLE TO REMOVE THE DEVICE BY REMOVING THE BALLOON OVER THE WIRE. THERE WAS NO ANGULATION OR VESSEL TORTUOSITY NOTED, BUT THERE WAS VESSEL CALCIFICATION DUE TO A SIGNIFICANT AMOUNT OF CALCIFIED PLAGUE. THE PROCEDURE WAS ALREADY COMPLETED PRIOR TO THE DEVICE RUPTURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THE OCCURRENCE.

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

  MAUDE report 11297281 ↗
• MalfunctionNov 13, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED. ACCESS WAS GAINED FROM THE RIGHT FEMORAL ARTERY TARGETING THE STENOTIC LESION AT THE RIGHT ANTERIOR TIBIAL ARTERY. AFTER PASSING A WIRE GUIDE THROUGH THE LESION, THE BALLOON CATHETER WAS INFLATED THE FIRST TIME. HOWEVER, WHEN IT WAS INFLATED TO 10 ATM THE SECOND TIME, IT RUPTURED (PATIENT REFERENCE (B)(6)). IT WAS ALSO NOTED TO HAVE RUPTURED AT 8 ATM (PATIENT REFERENCE (B)(6)). THE PHYSICIAN CANCELLED THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836761 ↗
• MalfunctionApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE OF A RIGHT OCCLUDED POSTERIOR TIBIAL VESSEL, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCORDING TO THE INITIAL REPORTER, THE BALLOON DEVICE WAS INSERTED INTO A 4FR SHEATH VIA PEDAL ACCESS THEN ADVANCED TO THE POSTERIOR TIBIAL VESSEL. UPON INFLATING THE DEVICE USING A 70/30 CONTRAST TO SALINE SOLUTION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE USER REMOVED THE RUPTURED BALLOON AND USED A 3X4 BALLOON TO FINISH THE PROCEDURE. 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, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959336 ↗
• MalfunctionDec 13, 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 9466576 ↗
• MalfunctionMay 16, 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 8616129 ↗
• MalfunctionApr 24, 2019Flaked; Flaked

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

  Patient problems: No Patient Involvement

  MAUDE report 8546346 ↗
• MalfunctionOct 16, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER UNRAVELED. WHILE PREPARING THE COMPLAINT DEVICE FOR USE DURING AN ENDOVASCULAR THERAPY PROCEDURE OF A CHRONIC TOTALLY OCCLUDED SUPERFICIAL FEMORAL ARTERY, THE PHYSICIAN HAD DIFFICULTY REMOVING THE SHIPPING STYLET FROM THE CATHETER'S LUMEN. HE USED A HEMOSTAT DEVICE TO TRY TO REMOVE IT AND WAS SUCCESSFUL AFTER APPLYING MORE FORCE TO THE HEMOSTAT. WITH THE WIRE GUIDE ALREADY INSERTED IN THE PATIENT'S ANATOMY, THE COMPLAINT DEVICE WAS BEING ADVANCED WHEN IT BECAME STUCK ON THE WIRE GUIDE. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. AFTER REMOVAL, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER APPEARED ELONGATED AND WAS REPLACED WITH ANOTHER MANUFACTURER'S BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EFFECTS WERE REPORTED. ALTHOUGH A KINK WAS NOT NOTED, THE PHYSICIAN QUESTIONED IF A KINK COULD HAVE BEEN PRESENT MAKING IT DIFFICULT TO REMOVE THE STYLET INITIALLY. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971208 ↗
• MalfunctionJul 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BURST DURING A "RIGHT LEG RUNOFF" PROCEDURE. ACCESS WAS GAINED AT THE LEFT GROIN. UPON REACHING THE TARGET SITE, HEAVY CALCIFICATION WAS NOTED. THE DEVICE WAS INFLATED TO 3-4 ATMOSPHERES OF PRESSURE WHEN IT RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION FOR THE SHEATH USED DURING THE PROCEDURE WAS REQUESTED, BUT COULD NOT BE CONFIRMED AT THIS TIME. 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 7710545 ↗
• MalfunctionMay 10, 2018Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED THAT WHEN THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED FROM ITS STERILE PACKAGE, THE PHYSICIAN NOTICED THAT THE BALLOON MATERIAL WAS FRAYED, BUBBLED, AND NOT SMOOTH AS IT SHOULD BE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE MALE PATIENT WAS TO RECEIVE INTERVENTION FOR CRITICAL LIMB ISCHEMIA IN AN UNSPECIFIED LEG. A NEW ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502458 ↗
• MalfunctionMar 7, 2018Excess Flow or Over-Infusion; Leak/Splash; Excess Flow or Over-Infusion; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A PERIPHERAL ANGIOPLASTY WHILE PREPARING THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, A SYRINGE WAS CONNECTED TO THE PORT AND REVERSE SUCTION WAS PERFORMED. AIR ENTERED THE SYRINGE AT A FASTER RATE THAN WHAT IS EXPECTED. SALINE SOLUTION WAS THEN INJECTED, AND THE SOLUTION BEGAN TO LEAK OUT OF THE STRAIN RELIEF (WHERE THE HUB/SYRINGE PORT CONNECTS TO THE BALLOON DELIVERY SYSTEM). THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7320667 ↗
• MalfunctionDec 21, 2017Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER TIP BROKE OFF. THE BALLOON CATHETER DID NOT COME INTO CONTACT WITH A PATIENT. ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7140396 ↗
• MalfunctionJun 12, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DEVICE WAS USED FOR A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY (ATA) BUT IT RUPTURED AT THE FIRST ATTEMPT OF INFLATION DUE TO CALCIFICATION. THEREFORE, IT WAS REPLACED WITH A SHORT 14LP (3-2) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTION OF THE RUPTURE CANNOT BE DETERMINED AS THE DEVICE WILL NOT BE RETURNED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6633238 ↗
• MalfunctionMay 25, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTION USING AN ADVANCE 14 LOW PROFILE BALLOON CATHETER, THE TECH REALIZED THAT THE HUB SEPARATED FROM THE MAIN BODY OF THE CATHETER. IT WAS REPORTED THAT THIS OCCURRED PRIOR TO THE SECOND INSERTION OF THE BALLOON CATHETER, WHEN THE INFLATION DEVICE WAS ATTACHED TO THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590288 ↗
• MalfunctionApr 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED DURING A LOWER LEG ANGIOGRAM, USING AN ADVANCE 14 LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED DURING THE PROCEDURE. THE DIRECTION IN WHICH THE BALLOON RUPTURED IS UNKNOWN. NO PART OF THE BALLOON DETACHED FROM THE DEVICE. THE TARGETED LESION WAS THE ANTERIOR TIBIAL ARTERY. THE VESSEL WAS SAID TO HAVE NO ANGULATION AND ONLY MILD CALCIFICATION. THE INFLATION PRESSURE USED AT THE TIME OF RUPTURE WAS 6 ATM. CONTRAST MIXTURE WAS 3 ML OF CONTRAST AND 5ML OF SALINE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482328 ↗