Advance G50321Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002503219), received between Jun 22, 2016 and Nov 22, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857614 ↗
• MalfunctionMar 21, 2019Material Integrity Problem; Material Integrity Problem

  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 8440733 ↗
• MalfunctionFeb 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER AND AGE WAS UNDERGOING AN ENDOVASCULAR THERAPY PROCEDURE FROM THE FEMORAL ARTERY TO TREAT A SEVERELY CALCIFIED LESION BELOW THE KNEE. DURING THE PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS INFLATED TO 8 ATMOSPHERES( ATM) WITH AN UNKNOWN DEVICE AND CONTRAST WHEN IT RUPTURED. SEVERE CALCIFICATIONS WERE NOTED. TORTUOSITY WAS NOT NOTED. ANOTHER MANUFACTURER'S 3FR SHEATH WAS USED DURING THE CASE. THE BALLOON WAS NOT INFLATED INSIDE A STENT PRIOR TO RUPTURE. THE ENTIRE BALLOON WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THE DEVICE RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER MANUFACTURER'S DEVICE WITHOUT ADVERSE EFFECTS TO THE PATIENT. THERE ARE NO PHOTOS OR IMAGES AVAILABLE. ACCORDING TO THE CUSTOMER, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347210 ↗
• MalfunctionJun 14, 2018Failure to Advance

  THE COMPLAINANT REPORTED TORTUOSITY IN THE VESSELS BELOW THE KNEE AND A SEVERELY CALCIFIED LESION. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE LEFT GROIN TO THE SEVERELY CALCIFIED AND TORTUOUS LESION. HOWEVER, THE DEVICE COULD NOT PASS THROUGH THE LESION. AS A RESULT, PRE-DILATION WAS PERFORMED WITH ANOTHER MANUFACTURER'S BALLOON. THE OTHER MANUFACTURER'S DEVICE COULD NOT PASS THROUGH THE LESION EITHER. A THIRD MANUFACTURER'S BALLOON WAS THEN USED TO PASS THROUGH THE LESION AND COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE CATHETER WAS GOUGED/CUT. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7602053 ↗
• MalfunctionJun 13, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE BALLOON ANGIOPLASTY PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS USED, THE BALLOON RUPTURED LONGITUDINALLY LIKELY DUE TO CALCIFICATION . THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER ADVANCE BALLOON WAS ADDITIONALLY USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598059 ↗
• MalfunctionApr 24, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE GREEN, WINGED HUB OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER SEPARATED FROM THE STRAIN RELIEF (CATHETER SHAFT). THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. PER THE INITIAL REPORTER, 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 7454666 ↗
• MalfunctionJul 13, 2017Hole In Material; Leak/Splash

  THE INFORMATION RECEIVED INDICATED THAT DURING SECOND INFLATION OF THE BALLOON, CONTRACT WAS NOTED TO BE LEAKING. IT WAS CONCLUDED THAT THERE WAS A HOLE IN THE BALLOON AND ANOTHER PTX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORT INDICATED THAT A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES RELATED TO THE EVENT AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710750 ↗
• InjuryJun 22, 2016Material Separation; Material Separation

  AFTER THE PHYSICIAN DID A SUCCESSFUL ANGIOPLASTY, HE BEGAN REMOVING THE BALLOON FROM THE PATIENT'S BODY. AS HE WAS REMOVING THE BALLOON, HE FELT SOME RESISTANCE. AFTER HE REMOVED IT FROM THE PATIENT, HE NOTICED THAT THE BALLOON LOOKED SHORTER. HE QUICKLY LOOKED UNDER FLURO. AND NOTICE THE DISTAL PORTION OF THE BALLOON COMPLETELY SEPARATED FROM THE DELIVERY CATHETER. IT WAS ON THE WIRE AND LOCATED AT THE DISTAL PART OF THE SHEATH. THE PHYSICIAN TRIED EVERYTHING TO REMOVE THE PIECE OF THE BALLOON WITHOUT REMOVING THE WIRE, BUT NOTHING WOULD ADVANCE THROUGH THE SHEATH WITH THE WIRE IN PLACE. HE ENDED UP REMOVING THE HYDRO ST WIRE AND THE PART OF THE BALLOON MIGRATED DOWN TO THE DISTAL POPLITEAL. HE QUICKLY ADVANCED A GOOSE NECK SNARE AND RETRIEVED THE PART OF THE BALLOON. 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 Code Available

  MAUDE report 5742046 ↗