ACCESSORIES 22295-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648079627), received between Mar 23, 2018 and Jul 7, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K950752); 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Leak/Splash; Loose or Intermittent Connection; Difficult to Advance; Leak/Splash; Loose or Intermittent Connection; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE GUIDE WIRE ACCESSORY KIT WITH 115 RHV (ROTATING HEMOSTATIC VALVE) WAS NOTED TO NOT CLOSE PROPERLY, NOT ACHIEVING COMPLETE HEMOSTASIS AND BLOOD COMES OUT. ALSO WHEN THE VALVE IS COMPLETELY OPEN, IT IS VERY DIFFICULT TO PASS TWO 0.014 GUIDE WIRES THROUGH SINCE THERE'S RESISTANCE WHEN ADVANCING TWO AT ONCE. HOWEVER, THE PROCEDURE WAS FINISHED WITH THE SAME RHV. THERE WAS NO ADVERSE PATIENT EFFECT 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 17278759 ↗
• MalfunctionJul 7, 2023Leak/Splash; Loose or Intermittent Connection; Difficult to Advance; Leak/Splash; Loose or Intermittent Connection; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE GUIDE WIRE ACCESSORY KIT WITH 115 RHV (ROTATING HEMOSTATIC VALVE) WAS NOTED TO NOT CLOSE PROPERLY, NOT ACHIEVING COMPLETE HEMOSTASIS AND BLOOD COMES OUT. ALSO WHEN THE VALVE IS COMPLETELY OPEN, IT IS VERY DIFFICULT TO PASS TWO 0.014 GUIDE WIRES THROUGH SINCE THERE'S RESISTANCE WHEN ADVANCING TWO AT ONCE. HOWEVER, THE THE PROCEDURE WAS FINISHED WITH THE SAME RHV. THERE WAS NO ADVERSE PATIENT EFFECT 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 17278144 ↗
• MalfunctionJul 7, 2023Leak/Splash; Loose or Intermittent Connection; Difficult to Advance; Leak/Splash; Loose or Intermittent Connection; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE GUIDE WIRE ACCESSORY KIT WITH 115 RHV (ROTATING HEMOSTATIC VALVE) WAS NOTED TO NOT CLOSE PROPERLY, NOT ACHIEVING COMPLETE HEMOSTASIS AND BLOOD COMES OUT. ALSO WHEN THE VALVE IS COMPLETELY OPEN, IT IS VERY DIFFICULT TO PASS TWO 0.014 GUIDE WIRES THROUGH SINCE THERE'S RESISTANCE WHEN ADVANCING TWO AT ONCE. HOWEVER, THE THE PROCEDURE WAS FINISHED WITH THE SAME RHV. THERE WAS NO ADVERSE PATIENT EFFECT 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 17277981 ↗
• MalfunctionJul 7, 2023Leak/Splash; Loose or Intermittent Connection; Difficult to Advance; Leak/Splash; Loose or Intermittent Connection; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE GUIDE WIRE ACCESSORY KIT WITH 115 RHV (ROTATING HEMOSTATIC VALVE) WAS NOTED TO NOT CLOSE PROPERLY, NOT ACHIEVING COMPLETE HEMOSTASIS AND BLOOD COMES OUT. ALSO WHEN THE VALVE IS COMPLETELY OPEN, IT IS VERY DIFFICULT TO PASS TWO 0.014 GUIDE WIRES THROUGH SINCE THERE'S RESISTANCE WHEN ADVANCING TWO AT ONCE. HOWEVER, THE THE PROCEDURE WAS FINISHED WITH THE SAME RHV. THERE WAS NO ADVERSE PATIENT EFFECT 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 17277895 ↗
• MalfunctionJun 20, 2018Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT A ROTATING HEMOSTATIC VALVE (RHV) WAS NOTED TO BE LEAKING AND THE ROTATING VALVE BECAME UNSCREWED/OPENED BY ITSELF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7622008 ↗
• MalfunctionMar 23, 2018Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SEAL OF THE ROTATING HEMOSTATIC VALVE WAS LOOSE AND A LEAK WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7366976 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K950752. One submission often covers many models, so check the product and lot details in each record.

• Z-2791-2011 · Jan 7, 2011 · Terminated
  Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.