Advance G52272Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002522722), received between Feb 21, 2017 and Dec 21, 2021 — classified as 4 injuries, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  INFORMATION WAS RECEIVED (B)(6) 2022 THAT THE EVENT REPORTED UNDER MANUFACTURER REPORT # 1820334-2021-02726 IS A DUPLICATE OF THE EVENT REPORTED UNDER MANUFACTURER REPORT # 1820334-2021-02643. NO FURTHER REPORTS WILL BE SENT UNDER MANUFACTURER REPORT # 1820334-2021-02726.

  Patient problems: Foreign Body In Patient

  MAUDE report 13054964 ↗
• InjuryDec 8, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12960490 ↗
• InjuryJun 20, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED VIA A MEDWATCH 3500A REPORT, DURING AN UNKNOWN PROCEDURE INVOLVING AN (B)(6) YEAR-OLD PATIENT, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON "POPPED" AND WAS DISLODGED IN THE PATIENT'S LEFT ARM. THE BALLOON WAS LATER REMOVED USING AN UNKNOWN SNARE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8715854 ↗
• MalfunctionAug 10, 2018Material 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 Known Impact Or Consequence To Patient

  MAUDE report 7774025 ↗
• MalfunctionJun 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST DURING AN UNSPECIFIED PROCEDURE ACCESSING THE FEMORAL ARTERY. THE DEVICE WAS INFLATED TO 10 ATMOSPHERES OF PRESSURE WHEN IT EXPERIENCED A LONGITUDINAL RUPTURE. THE VESSEL DID NOT CONTAIN ANY CALCIFICATION; HOWEVER, ANGULATION WAS REPORTED. AFTER THE RUPTURE, ANOTHER BALLOON DEVICE WAS USED TO COMPLETE THE PROCEDURE, THE PATIENT IS STABLE, AND NO ADVERSE EVENTS HAVE BEEN REPORTED. 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 7625599 ↗
• MalfunctionOct 19, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. IT WAS REPORTED THAT, DURING INFLATION, THE BALLOON BURST. THE VESSEL WAS REPORTED TO BE CALCIFIED. ANOTHER DEVICE WAS USED TO COMPLETE 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6962022 ↗
• MalfunctionJul 24, 2017Hole In Material; Inflation Problem

  IT WAS REPORTED DURING PERIPHERAL ANGIOPLASTY TO THE LEFT COMMON ILIAC ARTERY, THE BALLOON CROSSED THE LESION AND WHEN THERE WAS AN ATTEMPT TO INFLATE THE BALLOON IT WOULD NOT INFLATE. BLOOD WITHDREW INTO THE INJECTOR ON APPLYING NEGATIVE PRESSURE. AS A RESULT, THE LESION WAS DILATED WITH AN ALTERNATE BALLOON. THERE ARE NO KNOWN ADVERSE CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS ISSUE. IT WAS ALSO NOTED THAT A PINHOLE WAS APPROXIMATELY 1.5 CM FROM THE PROXIMAL MARKER-BAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6735987 ↗
• MalfunctionApr 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ADVANCE 35 LOW PROFILE BALLOON CATHETER WAS BEING USED FOR PRE-DILATION OF AN IN-STENT OCCLUSION OF AN ILIAC ARTERY WHEN THE BALLOON RUPTURED. (1820334-2017-00704) IT IS UNKNOWN IN WHICH DIRECTION THE BALLOON RUPTURED. AN ATTEMPT WAS MADE TO USE A SECOND BALLOON CATHETER; HOWEVER IT RUPTURED ALSO. (1820334-2017-00705) ANOTHER MANUFACTURER'S DEVICE WAS THEN USED TO PERFORM PRE-DILATION. AFTER ANOTHER MANUFACTURER'S STENT PLACEMENT, AND DURING POST-DILATION, THE VESSEL RUPTURED. A STENT GRAFT OF ANOTHER MANUFACTURER WAS THEN PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482687 ↗
• InjuryFeb 21, 2017Break; Kinked; Material Rupture; Stretched; Break; Kinked; Material Rupture; Stretched

  IT WAS REPORTED TO CUSTOMER RELATIONS, DURING AN ANGIOPLASTY PROCEDURE THE BALLOON OF THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST INSIDE THE PATIENT. DURING THE PROCEDURE, THE EXOPHYTIC CALCIFIED STENOTIC LESION DILATED WAS IN LEFT POPLITEAL ARTERY, WITH A RIGHT COMMON FEMORAL APPROACH OVER THE AORTIC BIFURCATION, THROUGH ANOTHER MANUFACTURER'S SHEATH USING ANOTHER MANUFACTURER'S WIRE. A RADIAL TEAR OF THE BALLOON OCCURRED. THE TORN DISTAL END OF THE BALLOON SNAGGED IN THE SHEATH AS THE BALLOON WAS BEING WITHDRAWN. THE CATHETER SHAFT STRETCHED AND THEN BROKE. HALF OF THE DEVICE WAS RECOVERED BY THE RADIOLOGIST VIA SNARES. THE REST OF THE BALLOON FRAGMENT REMAINED LODGED IN RIGHT COMMON FEMORAL ARTERY WHEN THE SHEATH WAS REMOVED. THE PATIENT UNDERWENT SUCCESSFUL FOREIGN BODY RETRIEVAL AND RIGHT COMMON FEMORAL ARTERY ENDARTERECTOMY LATER ON THE SAME DAY. AS OF POST-OP DAY 2 THERE WAS NO IMMEDIATE COMPLICATIONS. NO FURTHER DETAILS HAVE BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6346576 ↗