Advance G44145Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002441453), received between Feb 2, 2015 and Oct 24, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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 18, 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.

• InjuryOct 24, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING A FISTULAGRAM INVOLVING A (B)(6) FEMALE PATIENT, WEIGHING APPROXIMATELY (B)(6) A ATB ADVANCE BALLOON CATHETER RUPTURED AND SEPARATED INSIDE THE PATIENT. REPORTEDLY, THE BALLOON WAS DELIVERED OVER A COOK WIRE GUIDE AND WAS INFLATED ONCE IN THE LEFT INNOMINATE VEIN USING A COOK INFLATION DEVICE AND OMNIPAQUE 300 CONTRAST. THE PATIENT'S ANATOMY WAS REPORTED TO BE ANGULATED, WITH A 90-DEGREE ANGLE REPORTED. THE BALLOON WAS INFLATED TO 5 ATMOSPHERES, VERY SLOWLY, AND THE CUSTOMER NOTICED THE CENTER OF THE BALLOON WAS SMALLER THAN THE ENDS. THE CUSTOMER WAS REPORTEDLY WORKING IN THE INNOMINATE VEIN AND THE SUPERIOR VENA CAVA AT THE TIME OF INFLATION, AND THE BALLOON WAS INFLATED NEXT TO A PRE-EXISTING, UNKNOWN MANUFACTURER'S STENT. THE CUSTOMER FELT A POP, AT WHICH TIME THE DEVICE IS THOUGHT TO HAVE RUPTURED CIRCUMFERENTIALLY, AT 5 ATMOSPHERES. THE BALLOON WAS PULLED BACK, OVER THE COOK WIRE GUIDE AND WITH ANOTHER MANUFACTURER'S SHEATH, AND THE BALLOON WAS OBSERVED TO BE SHEARED OFF. USING ULTRASOUND, THE TIP OF THE DEVICE WAS CONFIRMED TO BE IN THE PATIENT'S LEFT ARM. THE USER ATTEMPTED TO REMOVE THE DEVICE WITH ANOTHER MANUFACTURER'S SNARE; HOWEVER, THE SEPARATED PO

  Patient problems: Foreign Body In Patient

  MAUDE report 9234719 ↗
• MalfunctionApr 11, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE BACK HUB BROKE/CRACKED OFF OF THE ATB ADVANCE BALLOON CATHETER AFTER ATTACHING THE INFLATION DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING ANOTHER ATB ADVANCE BALLOON CATHETER. 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 7420785 ↗
• InjuryApr 1, 2016Material Rupture; Material Rupture

  DURING A BILATERAL PTA OF THE JUGULAR VEIN, THE BALLOON BURST DURING INFLATION AND HAD TO BE REMOVED FROM PATIENT. THE INCIDENT WITH THE BALLOON OCCURRED ON THE LEFT SIDE. BEFOREHAND, THEY WORKED ON THE RIGHT SIDE WITH A SECOND BALLOON WITHOUT ANY PROBLEMS (THE USER FACILITY ALWAYS TAKES A NEW BALLOON FOR EACH SIDE). NORMAL PLACEMENT OF THE ATB BALLOON OVER A WIRE GUIDE THROUGH A 8 FR INTRODUCER. THE BALLOON WAS INFLATED WITH 5 ATM. THEN THE USER FACILITY SAW THAT THEY HAD LOST A PART OF THE BALLOON. THEY WITHDREW EVERYTHING INSIDE THE SHEATH AND WITHDREW THE SHEATH AS WELL. AFTERWARDS, THEY CUT THE SHEATH TO CHECK IF THE REST OF THE BALLOON WAS INSIDE THE SHEATH, BUT IT WAS NOT. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. HERE THE REST OF THE BALLOON WAS FOUND INSIDE THE LUNG. THE PIECE WAS TAKEN OUT WITH A SNARE. THE PHYSICIANS OF THE HOSPITAL BELIEVE THAT THEY HAVE FOUND EVERYTHING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT'S CONDITION WAS NORMAL DURING THE WHOLE PROCEDURE THERE WERE NO SIGNS IN THE EKG.

  Patient problems: No Code Available

  MAUDE report 5541621 ↗
• InjuryFeb 2, 2015Balloon rupture

  DURING A PTA OF SUBCLAVIAN, THE PHYSICIAN INFLATED THE DEVICE TWICE WITH NO INCIDENT. ON THE THIRD CIRCUMFERENTIAL RUPTURE, ALL FRAGMENTS WERE ABLE TO BE REMOVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign body, removal of

  MAUDE report 4491336 ↗