Advance G52270Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002522708), received between Jul 18, 2017 and Mar 3, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• InjuryMar 3, 2022Break; Material Rupture; Break; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY VIA CONTRALATERAL ACCESS, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED. ANOTHER MANUFACTURER'S 6 FRENCH SHEATH WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE COMPLAINT DEVICE WAS USED FOR SUBINTIMAL RECANALIZATION OF A LONG LESION WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT TORTUOUS, BUT SCATTERED CALCIFICATION WAS NOTED. AN INFLATION DEVICE WAS USED TO INFLATE THE DEVICE TO FOURTEEN ATMOSPHERES, USING A 50:50 RATIO OF OMNIPAQUE CONTRAST TO SALINE. THE FIRST AND SECOND INFLATIONS LASTED TWO MINUTES EACH. THE DEVICE WAS MOVED TO DIFFERENT POSITIONS BETWEEN INFLATIONS. UPON THE THIRD INFLATION OF THE BALLOON TO FOURTEEN ATMOSPHERES, THE BALLOON RUPTURED. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. AFTER THE BALLOON RUPTURED, THE USER ATTEMPTED TO REMOVE THE DEVICE OVER A WIRE; HOWEVER, THE BALLOON CATHETER WOULD NOT WITHDRAW INTO THE OTHER MANUFACTURER'S SHEATH. THE USER ATTEMPTED TO PASS A BUDDY WIRE TO REMOVE THE DEVICE. NEGATIVE PRESSURE WAS MAINTAINED WITH THE INFLATION DEVICE. THE USER THEN PULLED "REASONABLY FIRM¿, AND THE BALLOON CATH

  Patient problems: Foreign Body In Patient

  MAUDE report 13660474 ↗
• MalfunctionMay 21, 2021Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864187 ↗
• MalfunctionFeb 25, 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 9752866 ↗
• MalfunctionMay 7, 2019Material Separation; Material Separation

  IT WAS REPORTED ON 17FEB2019, A PHYSICIAN HAD A "SITUATION" WITH AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WHICH BECAME LODGED IN A FIFTY-FIVE CM, FIVE FR SHEATH (COOK). THE PHYSICIAN CUT THE SHEATH AFTER IT WAS WITHDRAWN FROM THE PATIENT. THE BALLOON WAS STUCK NEAR THE VALVE. ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING DETAILS OF THIS EVENT. A RESPONSE WAS RECEIVED 25APR2019 FROM THE PHYSICIAN, WHO PROVIDED THE FOLLOWING INFORMATION: "I USED A LONG 5FR SHEATH IN AN UP AND OVER FASHION TO THE CONTRALATERAL LEG. I USED A BALLOON TO PERFORM MULTIPLE ANGIOPLASTIES. UPON RETRIEVING THE BALLOON, IT BECAME STUCK IN THE SHEATH. I TRIED PULLING THE BALLOON WITH NEGATIVE PRESSURE WITHOUT SUCCESS. I TRIED REPEATEDLY TO REMOVE THE BALLOON UNTIL THE BALLOON RIPPED AND BECAME STUCK IN THE SHEATH. I EVENTUALLY NEEDED TO PULL THE SHEATH WITH THE BALLOON REMNANT AND WIRE AND LOST ACCESS BEFORE THE CASE WAS COMPLETE. I THEN CUT THE SHEATH AND FOUND THAT THE BALLOON WAS STUCK AT THE MEMBRANE AT THE SHEATH ENTRY SITE." NO PATIENT ADVERSE EFFECT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588202 ↗
• MalfunctionMay 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A RIGHT LOWER EXTREMITY ANGIOGRAM, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AFTER INFLATION OVER THE RATED BURST PRESSURE (RBP) OF 10 ATMOSPHERES (ATM). THE PATIENT WAS A (B)(6) YEAR OLD, NON-OBESE MALE. THE LEFT GROIN WAS ACCESSED WITH A 6 FRENCH (FR) SHEATH UP AND OVER TO THE RIGHT COMMON FEMORAL ARTERY (CFA). A STIFF GLIDE WIRE WAS USED DOWN THE SUPERIOR FEMORAL ARTERY (SFA) STATUS POST 1.5MM CROWN CSI ATHERECTOMY DEVICE. THE COMPLAINT DEVICE WAS USED FOR PRE-DILATION OF THE VESSEL AND WAS INFLATED IN THE POPLITEAL ARTERY/DISTAL SFA AND OVERLAPPING INFLATIONS IN THE MID SFA AND PROXIMAL SFA. THE SECOND TWO INFLATIONS WERE AT 16 ATM WHICH IS ABOVE THE RBP. THE VESSELS WERE SEVERELY CALCIFIED AND ON THE THIRD INFLATION AT 16 ATM, THE COMPLAINT DEVICE RUPTURED LONGITUDINALLY. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS EXCHANGED OUT FOR A DIFFERENT BALLOON FOR POST DILATION OF THE VESSEL AFTER THE STENT WAS DEPLOYED. PER THE COMPLAINANT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PORTION OF THE COMPLAINT DEVICE REMAINED IN THE PATIENT'S ANATOMY AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554114 ↗
• MalfunctionMay 17, 2018Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO SECTION H10 FOR INVESTIGATION FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523339 ↗
• MalfunctionApr 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM) INFLATION PRESSURE. THERE WAS NO VESSEL ANGULATION OR CALCIFICATION. NONIONIC CONTRAST WITH A RATIO OF 7ML CONTRAST TO 3ML 0.9% SALINE SOLUTION WAS USED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE COMPLAINANT, THE PATIENT REMAINED STABLE THROUGH THE END OF THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454715 ↗
• MalfunctionJan 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS NOT INFLATED DUE TO LEAKAGE AT THE PROXIMAL END OF THE BALLOON. ANOTHER BALLOON CATHETER 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 7183635 ↗
• MalfunctionJul 18, 2017Burst Container or Vessel

  IT WAS REPORTED THE BALLOON BURST. FIRST INFLATION WAS MADE IN DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT DIFFICULTY. THE BALLOON WAS THEN PULLED BACK FOR SECOND INFLATION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATM) AND IMMEDIATELY BURST. THE BALLOON WAS PULLED OUT AND THERE WAS NO HARM TO THE PATIENT. A NEW BALLOON OF UNKNOWN SIZE FROM THE SAME MANUFACTURER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723794 ↗