ACCESSORIES 22295Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648013331), received between Apr 28, 2023 and Jan 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Loose or Intermittent Connection; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN ATTACHING THE PRESSURE-RESISTANT TUBE TO THE Y-CONNECTOR, THE HUB PORTION WAS STIFF AND DIFFICULT TO FIT, THE DEVICES COULD NOT BE FULLY CONNECTED. THE DEVICE WAS NOT USED AND A NEW ONE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199909 ↗
• MalfunctionSep 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE GUIDE WIRE ACCESSORY KIT ROTATING HEMOSTASIS VALVE, THE LOCKING CONNECTION WAS POORLY ENGAGED WITH THE SYRINGE AND DID NOT CONNECT FIRMLY. A NEW ACCESSORY KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159432 ↗
• MalfunctionDec 6, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE ROTATING HEMOSTATIC VALVE (RHV) WAS FLUSHED INITIALLY AS IT WAS DIFFICULT TO TIGHTEN THE DEVICE WHEN CONNECTING THE GUIDING CATHETER. WHEN THE RHV WAS CONNECTED TO APPLY PRESSURE TO A BALLOON IN THE CAROTID ARTERY, CONTRAST LEAKED FROM THE CONNECTION. DESPITE CONNECTING THE DEVICES AGAIN, CONTRAST STILL LEAKED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND 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 18279267 ↗
• MalfunctionApr 28, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN USING A ROTATING HEMOSTATIC VALVE (RHV) FROM THE GUIDEWIRE (GW) ACCESSORY KIT, A LEAK OF CONTRAST WAS NOTED AT THE CONNECTION. THEREFORE, THE RHV WAS REPLACED WITH A NEW RHV. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834758 ↗

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.