Advance G50317Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002503172), received between Apr 11, 2017 and Mar 28, 2023 — classified as 1 injury, 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  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 16627772 ↗
• MalfunctionOct 6, 2022Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15552468 ↗
• MalfunctionJan 6, 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 9553470 ↗
• InjuryOct 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: No Code Available

  MAUDE report 9167875 ↗
• MalfunctionSep 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  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 9130828 ↗
• MalfunctionJul 26, 2019Material Puncture/Hole; Material Puncture/Hole

  AS ORIGINALLY REPORTED, DURING BALLOON DILATION OF THE ANTERIOR TIBIAL ARTERY, INVOLVING A (B)(6) YEAR-OLD MALE PATIENT, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WOULD NOT INFLATE PAST 2 ATMOSPHERES. NO DAMAGE WAS OBSERVED ON INITIAL INSPECTION OF THE DEVICE. AFTER FLUSHING, THE USER ADVANCED THE BALLOON CATHETER OVER A PRE-POSITIONED COOK 0.014 INCH WIRE GUIDE. PER THE INITIAL REPORTER, "NEGATIVE PRESSURE COULD ONLY APPLY TO 2 ATM/BAR" AND BLOOD VELOCITY INCREASED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE BALLOON AND UNKNOWN SHEATH WERE REMOVED AS A UNIT AND A NEW COOK DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION STATED THAT THE CUSTOMER DID NOT NOTICE ANY OBVIOUS LEAKS ON THE DEVICE. ANOTHER MANUFACTURER'S PRESSURE PUMP WITH PRESSURE INDICATOR WAS USED TO INFLATE THE DEVICE, USING AN UNKNOWN CONTRAST AGENT. THE PHYSICIAN CLARIFIED THAT IT WAS DIFFICULT TO APPLY PRESSURE/INFLATE BEYOND 2 ATMOSPHERES. NO CALCIFICATION, ANGULATION, OR TORTUOSITY WAS REPORTED. UPON RETURN AND INITIAL INVESTIGATION OF THE DEVICE, A PINHOLE RUPTURE WAS FOUND. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832754 ↗
• MalfunctionJun 13, 2018Leak/Splash

  IT WAS REPORTED THAT DURING THE EVT PROCEDURE AND USE OF A LOW PROFILE BALLOON CATHETER, THERE WAS CONTRAST MEDIA LEAKAGE FROM THE COILED-WIRE SHAFT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7595833 ↗
• MalfunctionJun 12, 2018Leak/Splash

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE OF USING ADVANCE LOW PROFILE BALLOON CATHETER, THERE WAS A LEAKAGE FROM THE HUB. SINCE THE PROCEDURE WAS ALMOST DONE, IT WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593458 ↗
• MalfunctionJan 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER (REFER TO MEDWATCH 1820334-2018-00331) WAS CONTRALATERALLY ADVANCED FROM THE COMMON FEMORAL ARTERY (CFA) TO THE BELOW THE KNEE (BK) LESION. THE BALLOON RUPTURED AS IT WAS ATTEMPTED TO BE INFLATED AT THE LESION. ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, FROM A SEPARATE LOT NUMBER WAS ATTEMPTED TO BE UTILIZED TO COMPLETE THE PROCEDURE; HOWEVER, IT RUPTURED AS WELL. ANOTHER MANUFACTURER'S DEVICE 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 Known Impact Or Consequence To Patient

  MAUDE report 7221723 ↗
• MalfunctionJan 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS CONTRALATERALLY ADVANCED FROM THE COMMON FEMORAL ARTERY (CFA) TO THE BELOW THE KNEE (BK) LESION. THE BALLOON RUPTURED AS IT WAS ATTEMPTED TO BE INFLATED AT THE LESION. ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER (REFER TO MEDWATCH 1820334-2018-00332) WAS ATTEMPTED TO BE UTILIZED TO COMPLETE THE PROCEDURE; HOWEVER, IT RUPTURED AS WELL. ANOTHER MANUFACTURER'S DEVICE 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 Known Impact Or Consequence To Patient

  MAUDE report 7221663 ↗
• MalfunctionDec 21, 2017Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE DEVICE WAS ADVANCED USING AN IPSILATERAL APPROACH FROM THE RIGHT FEMORAL ARTERY TO THE POSTERIOR TIBIAL ARTERY OF THE OCCLUDED ATA. THE BALLOON RUPTURED DURING THE SECOND ATTEMPT OF DILATION. IT WAS REPORTED THAT IT WAS UNKNOWN IF THE RUPTURE WAS LONGITUDINALLY OR CIRCUMFERENTIALLY. THE REPORTER STATED IT WAS BELIEVED BY THE PHYSICIAN THAT THIS OCCURRENCE WAS PROBABLY DUE TO THE CALCIFIED LESION. ANOTHER COOK PTAX4 BALLOON OF A DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE SINCE ANOTHER ATTEMPT OF DILATION WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138185 ↗
• MalfunctionNov 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS INSERTED FROM THE RIGHT GROIN AND ADVANCED TO THE ANTERIOR TIBIAL ARTERY (ATA). THE BALLOON CATHETER RUPTURED AT 6 ATM, BEFORE REACHING NOMINAL PRESSURE. THE DIRECTION (CIRCUMFERENTIALLY OR LONGITUDINALLY) OF THE BALLOON RUPTURE WAS REPORTED AS UNKNOWN. ANOTHER MANUFACTURER'S DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PATIENT HAD CRITICAL LIMB ISCHEMIA (CLI) PRIOR TO THE PROCEDURE; NO CALCIFICATION WAS PRESENT IN THE PATIENT'S ANATOMY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7032536 ↗
• MalfunctionSep 27, 2017Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR A DILATION PROCEDURE IN THE RIGHT GROIN. IT WAS REPORTED THAT, WHEN THE BALLOON WAS DILATED IN THE LESION, THE COILED-WIRE SHAFT BECAME SWOLLEN BEFORE REACHING TO THE PRESCRIBED PRESSURE. IT WAS THEN NOTED THAT CONTRAST MEDIA WAS LEAKING. ANOTHER ADVANCE BALLOON OF THE SAME SPECIFICATIONS WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. DURING THE MANUFACTURER'S INVESTIGATION OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, RECEIVED FOR THE ABOVE NON-REPORTABLE EVENT, DEVICE FAILURE ANALYSIS SHOWED THE BALLOON HAD A PINHOLE LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896854 ↗
• MalfunctionApr 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR TREATMENT (EVT), USING AN ADVANCE 14 LOW PROFILE BALLOON CATHETER, THE DEVICE WAS ADVANCED CONTRALATERALLY FROM THE FEMORAL ARTERY (FA). THE PATIENT'S ANATOMY WAS SAID TO BE SUITABLE FOR THE PROCEDURE HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON AT THE TARGET LESION, THE BALLOON RUPTURED. IT IS UNKNOWN THE DIRECTION IN WHICH THE BALLOON RUPTURED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6481039 ↗