Advance G50336Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002503363), received between Jun 8, 2018 and May 18, 2022 — classified as 1 injury, 3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, THE HUB OF AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER "SNAPPED OFF" UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT'S ANATOMY WAS REPORTEDLY CALCIFIED, AND ANOTHER MANUFACTURER'S BALLOON AND CATHETER ALSO BROKE DURING THE PROCEDURE. THE CASE WAS DESCRIBED AS "TRICKY". THE PHYSICIAN CLAMPED THE WIRE PORT TO FREE THE BALLOON FROM CALCIUM, AND NOTHING WAS LEFT IN THE PATIENT. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428599 ↗
• MalfunctionNov 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED WHILE TREATING A LESION IN A 65 YEAR OLD FEMALE THE CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA WAS NOT TORTUOUS. THE PHYSICIAN INFLATED THE COMPLAINT BALLOON TO 14 ATMOSPHERES (ATM) WITH ANOTHER MANUFACTURER'S INFLATION DEVICE WHEN IT RUPTURED ON THE FIRST INFLATION. NO BLOOD WAS NOTED IN THE INFLATION DEVICE. TYPE OF CONTRAST IN USE WAS UNKNOWN; HOWEVER, A 50/50 CONTRAST/SALINE MIXTURE WAS REPORTED. IT IS UNKNOWN IF THE COMPLAINT BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE PHYSICIAN BELIEVES A PIECE OF CALCIUM CAUSED THE RUPTURE. THE COMPLAINT DEVICE WAS REMOVED WITHOUT THE SHEATH AND ANOTHER MANUFACTURER'S BALLOON DEVICE WAS USED TO COMPLETE THE PERIPHERAL INTERVENTION PROCEDURE SUCCESSFULLY. 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 8067165 ↗
• 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 MEDWATCH 1820334-2018-01612). 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 (REFER TO THIS REPORT). 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 PR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624761 ↗
• MalfunctionJun 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN ANGIOPLASTY OF A FEMALE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE PHYSICIAN BROUGHT THE COMPLAINT DEVICE UP TO THE RECOMMENDED PRESSURE, AND IT RUPTURED AND LEAKED CONTRAST. OTHER MANUFACTURERS' DEVICES, ATHERECTOMY DEVICE AND CUTTING BALLOON, WERE USED PRIOR TO THE COMPLAINT DEVICE. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DID NOT SEPARATE OR DETACH. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. 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 AND NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582129 ↗