NA 622510Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04022495172532), received between Nov 18, 2016 and Apr 17, 2023 — classified as 85 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY. COMPLAINT: IN A SHUNT CASE. THE PRODUCT WAS USED TO EXPAND THE BALLOON AFTER PASSING THE WIRE. THE CUSTOMER FILLED THE LIQUID AT A RATIO OF 1:1 OF CONTRAST MEDIUM AND SALINE AND CLOSED THE THREE-WAY STOPCOCK, BUT AIR WAS DRAWN IN FROM SOMEWHERE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752154 ↗
• MalfunctionSep 16, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: COMPLAINT: WHEN PRESSURIZED, THE TURNING PART OF THE INFLATOR WAS NOTICEABLY STIFFER THAN NORMAL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436855 ↗
• MalfunctionSep 16, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: COMPLAINT: AIR WAS ENTERED WHEN TRYING TO PRESSURIZE THE BALLOON. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436846 ↗
• MalfunctionAug 30, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: DETAILS: IT WAS USED TO EXPAND THE BALLOON. HOWEVER, THE BALLOON WAS CONFIRMED EXPANDING ON CONTRAST RADIOGRAPHY, BUT THE PRESSURIZATION METER DID NOT INCREASE AND THE BALLOON EVENTUALLY RUPTURED. NO HEALTH HAZARD TO PATIENT AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323049 ↗
• MalfunctionJul 6, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: DETAILS: AFTER THE FIRST INFLATION AND DEFLATION, THERE WAS AN EVENT WHERE NO PRESSURE WAS APPLIED DURING THE SECOND INFLATION. THE USER REPLACED IT WITH A DIFFERENT INFLATOR AND USED IT, AND THE SURGERY WAS COMPLETED. THERE IS NO DAMAGE TO THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935693 ↗
• MalfunctionJun 13, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: AFTER PASSING THE 0.014 WIRE IN SFACTO OF THE SAME SIDE APPROACH, SABER X 4 MM 15 CM WAS USED IN PRE. AFTER THAT, THE USER TRIED TO PRESSURIZE WITH THE B. BRAUN INDEFLATOR, BUT THE PRESSURE DID NOT INCREASE. THE USER WAS ABLE TO USE THE SAME B. BRAUN DEFLATOR AND EXPAND WITHOUT PROBLEMS. THE STENT WAS PLACED AND THE PROCEDURE WAS SUCCESSFUL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675650 ↗
• MalfunctionJun 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IN A SHUNT PTA CASE, THE USER ATTEMPTED TO OPEN THE BALLOON FOR BALLOON DILATION USING THE PRODUCT AFTER PASSING THE WIRE. AT THAT TIME, THE USER FOUND A FOREIGN MATTER NEXT TO THE PACKAGE INSERT. THEREFORE, THE USER STOPPED USING IT. SURGERY COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER IDENTICAL PRODUCT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622857 ↗
• MalfunctionMay 3, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS: DURING PRESSURIZATION OF THE PRODUCT (TWO OF THE SAME LOT), AIR ENTERED FROM THE SIDE OF THE HANDLE AND THE PRESSURE DROPPED. AFTER CHANGING TO A DIFFERENT LOT, SURGERY COMPLETED WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270338 ↗
• MalfunctionMay 3, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS: DURING PRESSURIZATION OF THE PRODUCT (TWO OF THE SAME LOT), AIR ENTERED FROM THE SIDE OF THE HANDLE AND THE PRESSURE DROPPED. AFTER CHANGING TO A DIFFERENT LOT, SURGERY COMPLETED WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270323 ↗
• MalfunctionApr 20, 2022Leak/Splash; Activation Problem; Leak/Splash; Activation Problem

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: DETAILS: DURING PREPARATION FOR SURGERY, THE PRODUCT WAS FILLED WITH CONTRAST MEDIUM AND SALINE TO BLEED AIR IN ORDER TO EXPAND THE PRODUCT. AT THAT TIME, THE TIP WAS CONNECTED TO A THREE-WAY STOPCOCK. HOWEVER, IT COULD NOT BE USED BECAUSE AIR ENTERED FROM A PLACE OTHER THAN THE THREE-WAY STOPCOCK. THE PRODUCT WAS REPLACED AND SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159561 ↗
• MalfunctionApr 20, 2022Leak/Splash; Activation Problem; Leak/Splash; Activation Problem

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: DETAILS: DURING PREPARATION FOR SURGERY, THE PRODUCT WAS FILLED WITH CONTRAST MEDIUM AND SALINE TO BLEED AIR IN ORDER TO EXPAND THE PRODUCT. AT THAT TIME, THE TIP WAS CONNECTED TO A THREE-WAY STOPCOCK. HOWEVER, IT COULD NOT BE USED BECAUSE AIR ENTERED FROM A PLACE OTHER THAN THE THREE-WAY STOPCOCK. THE PRODUCT WAS REPLACED AND SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159559 ↗
• MalfunctionApr 20, 2022Leak/Splash; Activation Problem; Leak/Splash; Activation Problem

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: DETAILS: DURING PREPARATION FOR SURGERY, THE PRODUCT WAS FILLED WITH CONTRAST MEDIUM AND SALINE TO BLEED AIR IN ORDER TO EXPAND THE PRODUCT. AT THAT TIME, THE TIP WAS CONNECTED TO A THREE-WAY STOPCOCK. HOWEVER, IT COULD NOT BE USED BECAUSE AIR ENTERED FROM A PLACE OTHER THAN THE THREE-WAY STOPCOCK. THE PRODUCT WAS REPLACED AND SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159557 ↗
• MalfunctionApr 11, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: COMPLAINT: INFLATOR SYRINGE FAILURE INFLATION. DETAILS: WHILE USING THE PRODUCT, THE PRESSURE DID NOT RISE EVEN IF IT WAS TURNED MANY TIMES. USER STOPPED USING IT FOR SAFETY AND USED THE NEW ONE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072817 ↗
• MalfunctionFeb 24, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON ATTEMPTING TO INFLATE THE PRODUCT, THE PRODUCT DID NOT PRESSURIZE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595802 ↗
• MalfunctionFeb 24, 2022Deflation Problem; Deflation Problem

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON DEFLATING THE PRODUCT, THE GAUGE DID NOT REACH 0. THE SURGEON HAD TO DETACH THE PRODUCT AND DEFLATED IT WITH A SYRINGE. SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595774 ↗
• MalfunctionDec 4, 2021Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INFLATOR SYRINGE FAILED TO INFLATE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930321 ↗
• MalfunctionDec 3, 2021Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INFLATOR SYRINGE FAILED TO INFLATE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930198 ↗
• MalfunctionAug 20, 2021Activation Problem; Activation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN THE USER CONNECTED THE PRODUCT TO A BALLOON CATHETER AND APPLIED PRESSURE, THERE WAS A CLICKING SOUND AND THE PRESSURE DID NOT RISE AT ALL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349440 ↗
• MalfunctionJun 28, 2021Inflation Problem; Inflation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN THE USER TRIED TO PRESSURIZE TO EXPAND THE BALLOON, THE HANDLE DID NOT TURN WELL AND HE FELT UNEASY ABOUT THE PRODUCT AND STOPPED USING IT. A NEW PRODUCT WAS USED WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12074655 ↗
• MalfunctionJun 9, 2021Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED BY THE USER FACILITY: THE CUSTOMER TRIED TO CLEAN THE THREE-WAY STOPCOCK AT THE CONNECTION BY BLEEDING THE CLEANING AIR ACCORDING TO THE PROCEDURE MANUAL. HOWEVER, IT DID NOT ROTATE. THE DEVICE WAS TILTED RATHER THAN PROPERLY INSTALLED, AND THE SITUATION OF NON-ROTATION CONTINUED SEVERAL TIMES. THE CUSTOMER TRIED TO REPAIR IT BY USING FORCEPS, BUT THERE WAS A RISK OF DAMAGE, SO THE NEW PRODUCT WAS USED. THE PATIENT HAD NO HEALTH PROBLEMS AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970483 ↗
• MalfunctionJun 4, 2021Inflation Problem; Inflation Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INFLATOR SYRINGE FAILED TO INFLATE DURING USE. A NEW SYRINGE WAS USED AND THE SURGERY WAS COMPLETED. THE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937534 ↗
• MalfunctionJun 4, 2021Failure to Deflate; Failure to Deflate

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INFLATOR SYRINGE FAILED TO DEFLATE DURING USE. THE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937531 ↗
• MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN PRESSURE WAS APPLIED LEAKAGE OF CONTRAST MEDIUM WAS CONFIRMED FROM THE HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840354 ↗
• MalfunctionFeb 22, 2021Inflation Problem; Inflation Problem

  AS REPORTED BY THE USER FACILITY: THE THREE-WAY STOPCOCK WAS CRACKED, PREVENTING INFLATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11361979 ↗
• MalfunctionFeb 16, 2021Deflation Problem; Deflation Problem

  AS REPORTED BY THE USER FACILITY: THE DEFLATOR WAS OPENED TO EXPAND THE BALLOON. THE CLINICIAN ATTEMPTED TO CONNECT THE BALLOON AND THE INDEFLATOR, BUT THE RECESS WAS FOUND TO BE DEFORMED AND COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332896 ↗