Advance G50326Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002503264), received between Jan 16, 2018 and Jul 12, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INITIAL INFLATION IN THE PERINEAL ARTERY WITH AN UNSPECIFIED INFLATION DEVICE. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY OVER ANOTHER MANUFACTURER'S WIRE, AND THE ANATOMY WAS MILDLY CALCIFIED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733984 ↗
• MalfunctionOct 27, 2023Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS RECEIVED 01NOV2023. A 6-FRENCH COOK SHEATH WAS USED DURING THE PROCEDURE, AS WELL AS AN UNSPECIFIED INFLATION DEVICE. THE ANATOMY WAS STENOSED, AND THE BELOW-THE-KNEE LESION WAS SIXTY-TO-SEVENTY PERCENT OCCLUDED. THE TIP OF THE BALLOON LEAKED UPON THE FIRST INFLATION. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON CATHETER WAS REMOVED BY ITSELF. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021081 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER COULD NOT BE INFLATED DUE TO LEAKAGE FROM THE BALLOON. THE DEVICE WAS INSERTED THROUGH ANOTHER MANUFACTURER'S SHEATH TO ACCESS THE 70% OCCLUDED ANTERIOR TIBIAL ARTERY LESION. THE VESSEL WAS SLIGHTLY CALCIFIED BUT NEITHER TORTUOUS NOR ANGULATED. THE DEVICE WAS INFLATED ONCE TO 15 ATMOSPHERES FOR 30 SECONDS BEFORE LEAKAGE OF CONTRAST WAS DISCOVERED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. WHEN TESTING THE DEVICE OUTSIDE OF THE PATIENT, THE BALLOON WAS FOUND DAMAGED AND STILL COULD NOT BE INFLATED. 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 14013314 ↗
• MalfunctionFeb 14, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE AND USING A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, THE BALLOON QUICKLY LOST PRESSURE DUE TO A PINHOLE IN THE BALLOON MATERIAL. AN INFLATION DEVICE WAS USED. AND THE INFLATION PRESSURE DID NOT MAKE IT PAST 6ATM. INFLATION FAILED DURING THE FIRST ATTEMPT. A 5FR COOK SHEATH OF UNKNOWN LENGTH WAS ALSO UTILIZED DURING THE PROCEDURE. PATIENT'S ANATOMY WAS NOT NOTED TO BE TORTUOUS OR CALCIFIED. THE LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. THE BALLOON WAS REMOVED THROUGH THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524589 ↗
• MalfunctionJan 27, 2022Material Separation; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BROKE IN HALF. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13372994 ↗
• MalfunctionDec 15, 2021Material 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 13010262 ↗
• MalfunctionSep 29, 2021Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. CONTRALATERAL APPROACH WAS GAINED FROM THE LEFT COMMON FEMORAL ARTERY TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY, WHICH WAS SEVERELY CALCIFIED. ANOTHER MANUFACTURER'S SHEATH WAS ADVANCED ACROSS THE BIFURCATION, AND A WIRE WAS ADVANCED PAST THE STENOSED LESION. THE DEVICE WAS ADVANCED OVER THE WIRE GUIDE AND INFLATED ONE TIME TO 8 ATMOSPHERES USING AN INFLATION DEVICE BEFORE RUPTURING. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S BALLOON TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546913 ↗
• MalfunctionAug 3, 2021Material Rupture; Material Rupture

  INFORMATION WAS INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE PATIENT'S ANATOMY WAS CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268711 ↗
• MalfunctionNov 13, 2020Material Rupture; Material Rupture

  INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL MDR. THE ANATOMY WAS MODERATELY CALCIFIED AND THE LESION WAS 100% OCCLUDED. A PIN-HOLE RUPTURE WAS NOTED. AN UNKNOWN INFLATION DEVICE WAS USED. THE BALLOON WAS REMOVED BY ITSELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836814 ↗
• MalfunctionSep 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS AVAILABLE AND WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE LESION, LOCATED IN THE RIGHT MID ANTERIOR TIBIAL ARTERY, WAS 80% STENOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513705 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED ON 04FEB2020 NOTING THAT THE PROXIMAL END OF THE BALLOON WAS LEAKING BEFORE REACHING NOMINAL PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643675 ↗
• MalfunctionSep 12, 2019Material Separation; Material Separation

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER SEPARATED. THE PHYSICIAN REPORTED THAT THE WIRE WOULD NOT ADVANCE THROUGH THE DEVICE AND IT FELT AS THOUGH SOMETHING WAS STUCK. THE DEVICE REPORTEDLY SEPARATED "FULLY DOWN THE MIDDLE". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY HAD (B)(6). THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009899 ↗
• MalfunctionApr 26, 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 8555950 ↗
• MalfunctionMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  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 8453393 ↗
• MalfunctionMar 8, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED DURING ANGIOPLASTY OF AN UNSPECIFIED LEG, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS PLACED INSIDE THE ANTERIOR TIBIAL ARTERY AND INFLATED USING A COOK INFLATION DEVICE. INFLATION MEDIUM INFORMATION WAS NOT PROVIDED. ACCESS WAS GAINED FROM THE GROIN USING A COOK MICROPUNCTURE SET. NO INFORMATION WAS AVAILABLE REGARDING VESSEL SCARRING, TORTUOSITY, OR ANGULATION BUT IT WAS DESCRIBED AS "NOT OUT OF THE ORDINARY AND 50% STENOSED". THE GOAL WAS TO INFLATE THE DEVICE TO 8 ATMOSPHERES (ATM) BUT IT WOULD NOT INFLATE PAST 2 ATM. THE BALLOON WAS REMOVED FROM THE BODY AND INFLATED TO 8 ATM OUTSIDE OF THE STENT WITHOUT ISSUE. IT WAS REINSERTED ONCE AGAIN TO THE ANTERIOR TIBIAL ARTERY. AGAIN, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON BUT IT NEVER INFLATED. THE PATIENT WAS NOT HARMED AND THEY COMPLETED THE PROCEDURE WITH NO ISSUES." THE PROCEDURE WAS COMPLETED USING ANOTHER COOK BALLOON AND NO ADVERSE EFFECTS WERE REPORTED. UPON RECEIPT OF THE COMPLAINT DEVICE, A PINHOLE WAS FOUND DURING PRELIMINARY INVESTIGATION ON 27-FEB-2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404449 ↗
• MalfunctionJan 22, 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 8267254 ↗
• MalfunctionDec 11, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; 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 Known Impact Or Consequence To Patient

  MAUDE report 8152132 ↗
• MalfunctionAug 23, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, UPON OPENING THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, AN UNKNOWN GEL-LIKE SUBSTANCE WAS VISUALIZED ON THE BALLOON. THE PHYSICIAN DID NOT USE THE COMPLAINT DEVICE; THEREFORE, IT DID NOT MAKE CONTACT WITH THE PATIENT. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PERIPHERAL INTERVENTION PROCEDURE. NO ADVERSE EFFECT HAS BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810897 ↗
• MalfunctionJun 15, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS INFLATED, THE BALLOON RUPTURED LONGITUDINALLY. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605182 ↗
• MalfunctionJun 14, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED IPSILATERALLY TO TREAT THE "BK" LESION. THE BALLOON WAS PASSED THROUGH THE LESION, BUT IT RUPTURED. ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE PROCEDURE, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601984 ↗
• MalfunctionFeb 20, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT PRIOR TO A LOWER EXTREMITY ANGIOGRAM UPON OPENING THE PACKAGE AND PLACING THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER ON THE TABLE FOR FLUSHING, THE DEVICE WAS OBSERVED TO BE TORN DISTALLY AT THE TIP. THE LONGITUDINAL TEAR WAS APPROXIMATELY 1.5 CENTIMETERS (CM) FROM THE TIP. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT, NOR WAS IT INFLATED. 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 7282694 ↗
• MalfunctionJan 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE PATIENT'S LESION AND RUPTURED WHEN IT WAS ATTEMPTED BE INFLATED AT 8 ATMOSPHERE (ATM). ACCESS TO THE LESION WAS GAINED FROM BRACHIAL ARTERY. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7194391 ↗