FlowGate2 90495Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00815742004953), received between May 10, 2018 and Sep 22, 2026 — classified as 5 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K153729); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1907-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862668 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN EMERGENCY THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE WAS USED. DURING INFLATION PROCESS INSIDE THE PATIENT, THE SUBJECT BALLOON WAS DIFFICULT TO INFLATE. THE PHYSICIAN SUSPECTED AIR LEAKAGE FROM THE BALLOON. THUS, THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632579 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN EMBOLIZATION SURGERY FOR NASOPHARYNGEAL CARCINOMA, THE PHYSICIAN SELECTED SUBJECT BALLOON CATHETER FOR BLOOD FLOW OCCLUSION. AFTER DELIVERING THE SUBJECT BALLOON CATHETER TO THE PROXIMAL END OF LESION, THE PHYSICIAN USED A 2 ML SYRINGE FOR INFLATION. IT WAS FOUND THAT THE CONTRAST AGENT DISPERSED AT THE DISTAL END OF THE SUBJECT BALLOON, AND IT COULD NOT INFLATE. THE PHYSICIAN THEN WITHDREW THE SUBJECT BALLOON CATHETER AND TRIED INFLATING IT. UPON INSPECTION, IT WAS DISCOVERED THAT THE BODY OF SUBJECT BALLOON WAS PERFORATED, AND THE LIQUID WAS EJECTING OUT FROM THE TIP OF IT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808676 ↗
• InjuryMar 27, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE SUBJECT BALLOON WAS USED IN THE PULMONARY PROCEDURE, HOWEVER WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE SUBJECT BALLOON, HE COULDN'T MANAGE TO DEFLATE IT THUS THE SUBJECT BALLOON WAS RETRACTED AND REMOVED FROM THE PATIENT'S BODY IN THE INFLATED STATE. A DELAY OF 30 MINUTES WAS REPORTED IN THE PROCEDURE WITH EXTENDED ANESTHESIA, PERFORATION AND BLEEDING DUE TO THE REPORTED EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21708200 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING NASOPHARYNGEAL CARCINOMA EMBOLIZATION PROCEDURE, THE OPERATOR USED THE SUBJECT BALLOON GUIDE CATHETER TO REACH THE PROXIMAL PART OF THE LESION AND ATTEMPTED TO INFLATE IT WITH A SYRINGE. HOWEVER, IT WAS DISCOVERED THAT THE CONTRAST MEDIUM DIFFUSED AT THE DISTAL END, AND THE SUBJECT BALLOON COULD NOT BE INFLATED. THE OPERATOR WITHDREW THE SUBJECT BALLOON GUIDE CATHETER AND DISCOVERED THAT THE BALLOON WAS PERFORATED AND WAS LEAKING FLUID. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125622 ↗
• MalfunctionJan 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN OPERATOR TRIED TO DEFLATE THE SUBJECT BALLOON OF BALLOON CATHETER, NOTHING HAPPENED DESPITE CONTINUOUS ASPIRATION AT THE BALLOON LUMEN. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. UPDATE: BASED ON ADDITIONAL INFORMATION RECEIVED FROM GFE RESPONSE ON 10-FEB-2025, IT IS CLARIFIED THAT THE SUBJECT BALLOON OF THE BALLOON GUIDE CATHETER FAILED TO DEFLATE OUTSIDE THE PATIENT DURING PREPARATION AND NOT INSIDE THE PATIENT DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114584 ↗
• MalfunctionNov 19, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ALTHOUGH THE BALLOON DEFLATED NORMALLY DURING A TEST INFLATION OUTSIDE THE BODY, IT FAILED TO DEFLATE INSIDE THE PATIENT DURING THE PROCEDURE. EVEN AFTER REPLACING THE SYRINGE, THE BALLOON STILL DID NOT DEFLATE AND WAS EVENTUALLY DEFLATED BY FORCEFULLY PULLING IT FROM THE INTERNAL CAROTID ARTERY TO THE COMMON CAROTID ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728029 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE BALLOON BURST/RUPTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669493 ↗
• MalfunctionJul 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING LEFT MIDDLE CEREBRAL ARTERY MCA M1 HEAVY LOAD THROMBOSIS CASE, THE OPERATOR PLACED THE SUBJECT BALLOON TO INTERNAL CAROTID ARTERY ICA C1 TAIL AND DILATED IT BUT THE SUBJECT BALLOON WAS NOT EXPANDED OBVIOUSLY. THE OPERATOR WITHDREW THE CATHETER OUT TO CHECK AND FOUND MIDDLE OF THE SUBJECT BALLOON HAD LIQUID LEAKED. REPLACED THE SUBJECT BALLOON WITH ANOTHER ONE TO FINISH THE PROCEDURE. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735457 ↗
• MalfunctionJan 23, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE SUBJECT BALLOON COULD NOT BE DEFLATED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568004 ↗
• MalfunctionJan 23, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE SUBJECT BALLOON COULD NOT BE DEFLATED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568003 ↗
• MalfunctionAug 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FOLLOWED THE STANDARD PROCEDURE TO INTRODUCE THE SUBJECT BALLOON INTO THE PATIENT ANATOMY. THE SUBJECT BALLOON RUPTURED WHEN INFLATING PRESSURE REACHED TO 6 ATM. PHYSICIAN REMOVED THE WHOLE SYSTEM AND FOUND THAT THE TIP OF THE INTERMEDIATE CATHETER WAS DEFORMED. THE PHYSICIAN REPLACED THE SUBJECT BALLOON WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546814 ↗
• MalfunctionJul 14, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THE SUBJECT BALLOON WAS NOT DEFLATING BEFORE REMOVING IT FROM INTERNAL CAROTID ARTERY ICA . HENCE DOCTOR HAD TO PULL OUT WITH OUT BALLOON DEFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322638 ↗
• MalfunctionMay 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED AFTER INSERTION INTO THE AORTA (SUBJECT BALLOON WAS NOT YET INFLATED) SPONTANEOUS BLOOD REFLUX IN THE BALLOON INFLATION CHANNEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970405 ↗
• MalfunctionDec 21, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO DEFLATE THE BALLOON (SUBJECT DEVICE) DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029428 ↗
• MalfunctionDec 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON RUPTURED INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975104 ↗
• MalfunctionOct 17, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) ACUTE OCCLUSION CASE, PHYSICIAN INFLATED THE BALLOON OF THE SUBJECT BALLOON CATHETER AND USED A STENT FOR THE THROMBECTOMY PROCEDURE. HE TRIED TO DEFLATE THE BALLOON, HOWEVER THE BALLOON COULD NOT BE DEFLATED AND RETRACTED OUT. PHYSICIAN USED SOME FORCE AND WAS ABLE TO WITHDRAW THE SUBJECT BALLOON CATHETER. THE BALLOON WAS INFLATED ON THE TABLE BUT IT WAS UNABLE TO BE DEFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620417 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH INTERNAL CAROTID ARTERY ANEURYSM, THE SUBJECT BALLOON WAS ONLY PARTIALLY INFLATED DURING USE AND WHEN REMOVED FROM PATIENT VASCULATURE, IT WAS FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418719 ↗
• MalfunctionAug 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE AT THE SECOND INFLATION UNDER RADIATION WITH ADAPTATION TO THE VESSEL WALL (A. CAROTIS COMMUNIS) SUDDENLY THE CONTRAST AGENT SPILLED OUT OF THE BALLOON (SUBJECT DEVICE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15186791 ↗
• MalfunctionJul 25, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE PHYSICIAN INFLATED THE BALLOON (SUBJECT DEVICE) INSIDE THE ARTERY, THE BALLOON (SUBJECT DEVICE) WAS ALREADY DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE BALLOON (SUBJECT DEVICE) HAD A HOLE/PERFORATION DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099910 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT BALLOON DEVICE BURST. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041496 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT BALLOON DEVICE BURST. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041375 ↗
• MalfunctionJul 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE THE BALLOON (SUBJECT DEVICE) COULD NOT BE INFLATED AND LEAKAGE WAS VISIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029186 ↗
• MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE INTERNAL CAROTID ARTERY (ICA) OCCLUSION CASE, PHYSICIAN PREPARED TO DILATE THE BALLOON OF THE SUBJECT BALLOON GUIDE CATHETER USING THE 1 ML SYRINGE. IT WAS INFLATED AT A NOMINAL PRESSURE BUT THE BALLOON OF THE SUBJECT BALLOON GUIDE CATHETER LEAKED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008539 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT BALLOON WOULD INFLATE AND HOLD PRESSURE BUT THE WORKING/IRRIGATING CHANNEL WAS LEAKING JUST BELOW THE FILL PORT AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY WITH A DIFFERENT BALLOON. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153729. One submission often covers many models, so check the product and lot details in each record.

• Z-2569-2018 · Apr 11, 2018 · Terminated
  FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)