RHV 23245Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648013386), received between Apr 10, 2017 and Jul 10, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE ROTATING H/V (RHV) WAS NOTED TO HAVE A LEAK. THE CAP WAS TIGHTENED BUT THE LEAKAGE WAS STILL OBSERVED. ANOTHER NON-ABBOTT-DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713546 ↗
• MalfunctionMay 13, 2024Material Separation; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION REPORTED THAT THE SEPARATED PORTION REMAINED IN THE BODY OF THE RHV AND DID NOT TRAVEL INTO THE PATIENT. THEREFORE, NO INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298382 ↗
• MalfunctionJul 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE ROTATING HEMOSTATIC VALVE WAS ATTACHED TO UNSPECIFIED DEVICES, AIR WAS OBSERVED TO BE COMING IN FROM THE VALVE. THEREFORE, THE DEVICE WAS REPLACED. THE SAME ISSUE OCCURRED WITH TWO MORE HEMOSTATIC VALVES. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069963 ↗
• MalfunctionJul 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE ROTATING HEMOSTATIC VALVE WAS ATTACHED TO UNSPECIFIED DEVICES, AIR WAS OBSERVED TO BE COMING IN FROM THE VALVE. THEREFORE, THE DEVICE WAS REPLACED. THE SAME ISSUE OCCURRED WITH TWO MORE HEMOSTATIC VALVES. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069935 ↗
• MalfunctionJul 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE ROTATING HEMOSTATIC VALVE WAS ATTACHED TO UNSPECIFIED DEVICES, AIR WAS OBSERVED TO BE COMING IN FROM THE VALVE. THEREFORE, THE DEVICE WAS REPLACED. THE SAME ISSUE OCCURRED WITH TWO MORE HEMOSTATIC VALVES. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069899 ↗
• MalfunctionJun 21, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE VALVE OF THE COPILOT WOULD NOT COMPLETELY CLOSE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754216 ↗
• MalfunctionJun 20, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE VALVE OF THE COPILOT WOULD NOT COMPLETELY CLOSE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747985 ↗
• MalfunctionJul 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE ROTATING HEMOSTATIC VALVE (RHV) DRAWS AIR. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT THE FOLLOWING INFORMATION WAS PROVIDED: ONE DEVICE WAS IN THE RHV WHEN IT WAS LEAKING. A NEW RHV WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168225 ↗
• MalfunctionJan 11, 2021Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN INTERVENTION, THE ROTATING HEMOSTATIC VALVE (RHV) WAS DIFFICULT TO SCREW TIGHT AND A LEAK WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152877 ↗
• MalfunctionNov 14, 2019Product Quality Problem; Unstable; Product Quality Problem; Unstable

  IT WAS REPORTED THAT BEFORE USE, THE O-RINGS OF THREE ROTATING HEMOSTATIC VALVES (RHV) WERE NOTED TO BE UNSTABLE. THEREFORE, A COPILOT WAS USED INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE CAP OF THE RHV LEAKED.

  Patient problems: No Patient Involvement

  MAUDE report 9322456 ↗
• MalfunctionNov 14, 2019Product Quality Problem; Unstable; Product Quality Problem; Unstable

  IT WAS REPORTED THAT BEFORE USE, THE O-RINGS OF THREE ROTATING HEMOSTATIC VALVES (RHV) WERE NOTED TO BE UNSTABLE. THEREFORE, A COPILOT WAS USED INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE CAP OF THE RHV LEAKED.

  Patient problems: No Patient Involvement

  MAUDE report 9322454 ↗
• MalfunctionNov 14, 2019Product Quality Problem; Unstable; Product Quality Problem; Unstable

  IT WAS REPORTED THAT BEFORE USE, THE O-RINGS OF THREE ROTATING HEMOSTATIC VALVES (RHV) WERE NOTED TO BE UNSTABLE. THEREFORE, A COPILOT WAS USED INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE CAP OF THE RHV LEAKED.

  Patient problems: No Patient Involvement

  MAUDE report 9322397 ↗
• MalfunctionApr 10, 2017Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL ARTERY. IT WAS REPORTED THAT TWO ROTATING HEMOSTATIC VALVES (RHV) WERE ATTEMPTED TO BE USED IN THE CASE; HOWEVER, WHEN THE VALVES WERE TURNED THEY DID NOT TIGHTEN ON THE GUIDE WIRE; WHICH, CAUSED LEAKING. A NEW RHV WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477277 ↗
• MalfunctionApr 10, 2017Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL ARTERY. IT WAS REPORTED THAT TWO ROTATING HEMOSTATIC VALVES (RHV) WERE ATTEMPTED TO BE USED IN THE CASE; HOWEVER, WHEN THE VALVES WERE TURNED THEY DID NOT TIGHTEN ON THE GUIDE WIRE; WHICH, CAUSED LEAKING. A NEW RHV WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477262 ↗