Advance G50340Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002503400), received between Jul 12, 2017 and Dec 27, 2024 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF A LOWER EXTREMITY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER¿S BALLOON RUPTURED. THE PATIENT¿S ANATOMY WAS MODERATELY CALCIFIED. AN UNKNOWN COOK 5-FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME WITHIN A LESION IN THE SUPERFICIAL FEMORAL/COMMON FEMORAL ARTERY; HOWEVER, THE BALLOON RUPTURED WITHIN FIFTEEN SECONDS, AT SIX ATMOSPHERES. THE BALLOON WAS NOT INFLATED WITHIN A STENT, AND BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE, AND NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL OF THE BALLOON CATHETER, WHICH WAS REMOVED BY ITSELF. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027170 ↗
• MalfunctionApr 3, 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 8478926 ↗
• InjuryMar 8, 2019Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8403904 ↗
• MalfunctionOct 22, 2018Material Frayed; Material Frayed

  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 7993715 ↗
• MalfunctionJul 16, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED, A "KINK/SNAP" WAS NOTED AT THE PROXIMAL END OF THE ACTUAL BALLOON DURING PREP OF THE DEVICE PRIOR TO USE IN THE PATIENT. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS BEING FLUSHED AT THE DISTAL END AS IT WAS BEING FED OVER THE .014 WIRE. ANOTHER BALLOON CATHETER WAS USED DURING THE PROCEDURE WHICH WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, NO PATIENT ADVERSE EVENT OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691090 ↗
• MalfunctionJun 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA), THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY WHEN INFLATED TO FOURTEEN ATMOSPHERES (REFER TO THIS REPORT). THE COMPLAINT DEVICE WAS INFLATED MULTIPLE TIMES AND DID NOT RUPTURE ON THE FIRST INFLATION. REPORTEDLY, THE VESSEL WAS CALCIFIED; HOWEVER, THERE WAS NO ANGULATION. TYPE OF CONTRAST IS UNKNOWN AS IS THE MIX OF CONTRAST TO SALINE. ANOTHER DEVICE, A DIFFERENT SIZE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FACILITY WAS ALSO TREATING A SECOND LESION IN THE CALCIFIED POPLITEAL ARTERY USING A SEPARATE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, AND THIS DEVICE ALSO RUPTURED AFTER SEVERAL INFLATIONS (REFERENCE MEDWATCH 1820334-2018-01611). INFLATION PRESSURE WAS FOURTEEN ATMOSPHERES. THIS SECOND COMPLAINT DEVICE RUPTURED CIRCUMFERENTIALLY. FOR THIS SECOND LESION, THE RUPTURE OCCURRED TOWARDS THE END OF THE PROCEDURE WHICH WAS COMPLETED SUCCESSFULLY WITHOUT THE NEED FOR ADDITIONAL PRODUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624762 ↗
• InjuryJan 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A VENOUS ANGIOPLASTY, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS INFLATED (UNSPECIFIED PRESSURE) AND THE BALLOON SHEARED OFF INSIDE OF THE PATIENT'S ANATOMY WHILE ADVANCING THE SHEATH OVER IT. THE EVENT OCCURRED WHILE MOVING ACROSS A VENOUS OCCLUSION IN THE ILIAC VEIN. THE BALLOON PIECE WAS ABLE TO BE SUCCESSFULLY RETRIEVED USING A SNARE. 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 Code Available

  MAUDE report 7232166 ↗
• MalfunctionDec 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PER EMAIL RECEIVED 28 DEC 2017: "THE WORD ¿FLUFF¿ HERE MEANS UNKNOWN FABRIC, I DON¿T KNOW HOW TO DESCRIBE IT."

  Patient problems: No Patient Involvement

  MAUDE report 7155330 ↗
• MalfunctionNov 20, 2017Material Separation; Material Separation

  DURING PREPARATION OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER FOR A FISTULOGRAM, IT WAS NOTED THAT PART OF THE TIP OF THE BALLOON WAS HANGING OFF WHEN IT CAME OUT OF THE HOOP. IT WAS REPORTED THAT AS THE TIP DID NOT FEEL RIGHT, ANOTHER BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, NO ADDITIONAL PROCEDURES WERE NEEDED AND NO ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046725 ↗
• InjurySep 6, 2017Material Rupture; Material Rupture

  AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED IN A PERIPHERAL INTERVENTION. IT WAS REPORTED THAT, THE BALLOON WAS INFLATED FOUR TIMES AT A MAXIMUM PRESSURE OF 16 ATM IN THE HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA); ON THE FOURTH INFLATION THE BALLOON BURST. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON OUT OF THE SHEATH IN THE RIGHT FEMORAL ARTERY, THE DISTAL TIP OF THE BALLOON CAUGHT ON THE HEMOSTATIC VALVE INSIDE OF THE SHEATH AND SEPARATED INTO TWO PIECES. A SUPPORT CATHETER WAS USED IN THE RIGHT FOOT ACCESS SITE TO PUSH THE REMAINING BALLOON PIECE OUT OF THE HEMOSTATIC VALVE. ALL PIECES OF THE BALLOON WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6846092 ↗
• MalfunctionJul 12, 2017Material Rupture

  DURING THE PROCEDURE THE BALLOON RUPTURED HORIZONTALLY (LONGITUDINALLY) THERE WAS NO HARM TO THE PATIENT, NOTHING DETACHED, NOTHING LEFT IN THE PATIENT. THE PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6707286 ↗