FlowGate2 90485Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00815742004854), received between May 15, 2018 and Dec 18, 2025 — classified as 2 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (18 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR MIDDLE CEREBRAL ARTERIES (MCA) OCCLUSION, THE PHYSICIAN PREPARED TO INFLATE THE SUBJECT BALLOON WITH A 1:1 MIXTURE OF NORMAL SALINE AND CONTRAST AGENT BUT FOUND THAT THE SUBJECT BALLOON DID NOT INFLATE. THE RESISTANCE WAS ENCOUNTERED WHEN INTERMEDIATE CATHETER WAS INSERTED INTO THE SUBJECT BALLOON CATHETER. AFTER REPEATEDLY PULLING AND PUSHING A 20ML SYRINGE TO EVACUATE AIR AND ATTEMPTING TO REINFLATE IT, THE BALLOON STILL FAILED TO INFLATE UNDER FLUOROSCOPIC EXAMINATION. AFTER THE PROCEDURE, THE PHYSICIAN INSPECTED THE SUBJECT BALLOON ON THE TABLE AND DISCOVERED THAT THE SUBJECT BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED DIRECTLY WITH THROMBECTOMY, AND THE VESSEL WAS SUCCESSFULLY RECANALIZED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836004 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT BALLOON GUIDE CATHETER WAS INSERTED INTO THE PATIENT'S BODY AND ATTEMPTED TO INFLATE THE BALLOON AT ICA; HOWEVER, THE SUBJECT BALLOON DID NOT INFLATE. WHEN THE DEVICE WAS REMOVED FROM THE BODY, THE MIDDLE PART OF THE SUBJECT BALLOON WAS FOUND TO BE LEAKED. THE BALLOON WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475886 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE BALLOON CATHETER (SUBJECT DEVICE) FRACTURED WITHIN THE PATIENT AND THE BALLOON WAS NOTED TO BE LEAKING WHEN IT WAS WITHIN THE PATIENT. 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 22337520 ↗
• MalfunctionFeb 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN ATTEMPTING TO INFLATE THE SUBJECT DEVICE, A PROBLEM OCCURRED WHERE THE OUTER JACKET OF THE SUBJECT DEVICE EXPANDED/SWELLED. BOTH INFLATION AND DEFLATION TOOK TIME, BUT THE BALLOON INFLATION WAS POSSIBLE. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359034 ↗
• MalfunctionDec 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING RIGHT M1 OCCLUSION MECHANICAL THROMBECTOMY PROCEDURE, SUBJECT BALLOON OF THE BALLOON CATHETER WAS RUPTURED WHEN APPROX. 0.5CC OF 50/50 CONTRAST SALINE WAS INJECTED INTO THE BALLOON. 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 20817170 ↗
• MalfunctionSep 9, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE SUBJECT BALLOON OF BALLOON CATHETER WAS FAULTY AND COULD NOT BE DEFLATED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173287 ↗
• MalfunctionAug 14, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) STENOSIS CASE, RESISTANCE WAS FELT WHILE INSERTING SUBJECT BALLOON CATHETER INTO THE SHEATH. WHEN REMOVED AND CHECKED, THE COATING ON THE SUBJECT BALLOON CATHETER WAS PEELED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982259 ↗
• MalfunctionMar 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. IT WAS REPORTED THAT ONLY THE SUBJECT BALLOON SHAFT WAS IN CONTACT WITH THE HEMOSTATIC VALVE. THEREFORE, THE SUBJECT BALLOON WAS REPLACED WITH A NON-STRYKER DEVICE AND IT WAS NOTED THAT THE BLOOD LEAKAGE WAS STOPPED 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 18969645 ↗
• MalfunctionAug 18, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR A CEREBRAL INFARCTION OF LEFT INTERNAL CAROTID ARTERY THE SUBJECT BALLOON DEVICE WAS INFLATED AND THE THROMBECTOMY WAS PERFORMED. FOLLOWING THIS THE PHYSICIAN ATTEMPTED TO DEFLATE THE SUBJECT BALLOON DEVICE BUT IT WOULD NOT DEFLATE. THE SUBJECT BALLOON DEVICE WAS WITHDRAWN TO THE AORTIC ARCH WHERE DEFLATION OF THE SUBJECT BALLOON DEVICE WAS SUCCESSFULLY COMPLETED. 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 17573799 ↗
• MalfunctionJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SUBJECT BALLOON CATHETER WAS GUIDED TO IC-CC, AND WHEN ATTEMPTING TO INFLATE THE SUBJECT BALLOON DURING INDUCTION OF A NON-STRYKER GUIDEWIRE, THE SUBJECT THE BALLOON DID NOT INFLATE, THEREFORE, THE SUBJECT BALLOON CATHETER WAS RETRIEVED. WHEN THE SUBJECT BALLOON CATHETER WAS VISUALLY EXAMINED, THE SUBJECT BALLOON WAS BROKEN. IT WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366173 ↗
• MalfunctionJun 9, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE BALLOON WAS ATTEMPTED TO DILATE, A LEAKAGE OF CONTRAST WAS FOUND. AFTER FURTHER ATTEMPTS TO DILATE, THE SUBJECT BALLOON WAS FOUND RUPTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101811 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE MEDICAL PROCEDURE, WHEN THE SUBJECT BALLOON WAS ADVANCED TO THE LESION AND ATTEMPTED TO DILATE, THE SUBJECT BALLOON RUPTURED. THE SUBJECT BALLOON 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 15921010 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE MEDICAL PROCEDURE, WHEN THE SUBJECT BALLOON WAS ADVANCED TO THE LESION AND ATTEMPTED TO DILATE, THE SUBJECT BALLOON RUPTURED. THE SUBJECT BALLOON 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 15920957 ↗
• MalfunctionNov 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO INFLATE THE SUBJECT BALLOON AND FOUND THAT IT WAS LEAKING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852868 ↗
• MalfunctionOct 11, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON WAS UNABLE TO DEFLATE WHICH RESULTED IN THE CATHETER FALLING OUT OF THE INTERNAL CAROTID ARTERY BACK INTO THE AORTA. 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 15575915 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN ADVANCED THE SUBJECT BALLOON GUIDE CATHETER TO THE COMMON CAROTID ARTERY (CCA). THE SUBJECT BALLOON WAS INFLATED, BUT THE CONTRAST MEDIUM LEAKED AND IT COULD NOT BE INFLATED. PATIENT¿S ANATOMY WAS VERY MEANDERING. 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 15419411 ↗
• MalfunctionJul 18, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH CAROTID ARTERY STENOSIS, THE SUBJECT BALLOON FAILED TO DEFLATE INSIDE THE PATIENT VASCULATURE. WHEN IT WAS ATTEMPTED TO BE REMOVED, IT GRADUALLY DEFLATED. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041537 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING BALLOON ANGIOPLASTY WITH STENT PLACEMENT PROCEDURE IN A PATIENT WITH CAROTID ARTERY STENOSIS, THE SUBJECT BALLOON DEFLATED ON ITS OWN INSIDE THE PATIENT ANATOMY. 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 14017214 ↗
• MalfunctionApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A NEUROVASCULAR PROCEDURE WAS PERFORMED IN A PATIENT FOR AIS (ACUTE ISCHEMIC STROKE). DURING PREPARATION AIR WAS EXTRACTED OUT OF THE SUBJECT BALLOON, BUT NO TEST OF THE SUBJECT BALLOON WAS PERFORMED PRIOR TO USE IN PATIENT. DURING THE PROCEDURE THE SUBJECT BALLOON BROKE INSIDE THE PATIENT. THE SUBJECT BALLOON WAS REPLACED WITH ANOTHER DEVICE AND 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 13983078 ↗
• MalfunctionMar 29, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SUBJECT BALLOON CATHETER WAS USED DURING IC (INTERNAL CAROTID ARTERY) NEURO-ENDOVASCULAR PROCEDURE FOR CEREBRAL INFARCTION. DURING PREPARATION SUBJECT BALLOON CATHETER WAS INFLATION AND DEFLATION SUCCESSFULLY. DURING PROCEDURE WHILE INSERTION OF THE SUBJECT BALLOON CATHETER, RESISTANCE WAS NOTED INTO THE INTRODUCER SHEATH. THE BALLOON WAS ADVANCED TO THE TARGETED LESION AND INITIALLY WHEN THE BALLOON WAS INFLATED, DEFLATION WAS NOT POSSIBLE. THREE-WAY STOPCOCK WAS REMOVED TO DEFLATE THE BALLOON. THE BALLOON WAS INFLATED AGAIN, AND PHYSICIAN PERFORMED THE PROCEDURE. WHEN PHYSICIAN TRIED TO DEFLATE IT BUT COULD NOT. THE THREE-WAY STOPCOCK WAS REMOVED IN THE SAME WAY AS BEFORE, BUT SINCE DEFLATION WAS NOT POSSIBLE, IT WAS RETRIEVED BY RUPTURING IT IN THE INTRODUCER SHEATH. 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 13944608 ↗
• MalfunctionDec 23, 2021Material Rupture; Material Rupture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE BALLOON WAS NOTED TO HAVE BEEN BURST/ RUPTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078896 ↗
• MalfunctionOct 22, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AFTER PTA WAS PERFORMED, THE SUBJECT BALLOON WAS ABLE TO INFLATE AND DEFLATE WITHOUT ANY PROBLEM DURING PREPARATION. WHILE THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SUBJECT BALLOON FROM THE PATIENT'S ANATOMY, THE SUBJECT BALLOON WOULD NOT DEFLATE. HOWEVER, THE PHYSICIAN RETRIEVED THE SUBJECT BALLOON TO THE INGUINAL REGION AND THEN REMOVED IT ALONG WITH THE SHEATH. 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 12685830 ↗
• MalfunctionOct 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SUBJECT BALLOON CATHETER WAS PREPARED AND DEFLATED ACCORDING TO INSTRUCTIONS. WHEN ATTEMPTING TO PLACE THE SUBJECT BALLOON CATHETER DURING THE PROCEDURE, IT FAILED TO INFLATE, NO INFLATION WAS SEEN ON X-RAY. THE SUBJECT BALLOON FAILED TO KEEP THE NACL/CONTRAST MIXTURE AND THE SUBJECT BALLOON WAS OBSERVED TO BE LEAKING. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667757 ↗
• MalfunctionAug 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SUBJECT DEVICE BALLOON CATHETER WAS USED FOR CAS (CAROTID ARTERY STENTING) TREATMENT. THERE WAS NO PROBLEM AT THE TIME OF PREPARATION, AND IT WAS USED IN THE PATIENT¿S BODY. DESPITE THE INJECTION OF CONTRAST MEDIUM DURING INFLATION, FLUOROSCOPY DID NOT CONFIRM THE EXPANSION OF THE SUBJECT BALLOON. SINCE THE OCCLUSION WAS CONFIRMED, THE PHYSICIAN CONTINUED TO USE IT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A LARGE AMOUNT OF BLOOD WAS CONFIRMED IN THE SUBJECT BALLOON AFTER COLLECTION. SINCE THERE WAS NO LEAKAGE FROM THE SUBJECT BALLOON, IT IS CONSIDERED THAT IT MAY HAVE FLOWED IN FROM THE INNER. IT IS PROBABLE THAT THE REASON WHY THE FLUOROSCOPY WAS NOT VISIBLE WAS THAT THE INSIDE OF THE SUBJECT BALLOON WAS FILLED WITH BLOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12290650 ↗
• MalfunctionJul 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT CAROTID ARTERY STENTING WAS PERFORMED. THE PATIENT WAS HAVING AVERAGE TORTUOUS VASCULATURE. AFTER PREPARING THE SUBJECT BALLOON CATHETER ACCORDING TO DFU, WHEN THE SURGEON WAS PUTTING PEEL-AWAY SHEATH OVER THE BALLOON PART, THERE WAS SOME RESISTANCE, BUT HE WAS ABLE TO PUT IT ON. AFTER ADVANCEMENT OF THE BALLOON INTO THE PATIENT VASCULATURE, WHEN THE SURGEON TRIED TO EXPAND THE SUBJECT BALLOON, THE BALLOON DID NOT EXPAND. SO, THE SURGEON REMOVED IT FROM THE BODY AND CONFIRMED THAT THE BALLOON WAS TORN. THE PHYSICIAN REPLACED IT WITH A NEW 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 12215530 ↗

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)