FlowGate2Recalls & reported problems across all models

We found 2 models of FlowGate2 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 157 adverse event reports in the FDA's MAUDE database, received between May 10, 2018 and Sep 22, 2026 — classified as 7 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (47 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FlowGate2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported FlowGate2 problems

FlowGate2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FlowGate2 90495

  CATHETER, PERCUTANEOUS
  1 recall94 reports
• FlowGate2 90485

  CATHETER, PERCUTANEOUS
  1 recall63 reports

Recent FlowGate2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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