ACCESSORIESRecalls & reported problems across all models

We found 3 models of ACCESSORIES by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2016 and May 7, 2026 — classified as 2 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (64 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. 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

Most reported ACCESSORIES problems

ACCESSORIES models

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

• ACCESSORIES 1003330

  WIRE, GUIDE, CATHETER
  72 reports
• ACCESSORIES 22295-115

  WIRE, GUIDE, CATHETER
  6 reports
• ACCESSORIES 22295

  WIRE, GUIDE, CATHETER
  4 reports

Recent ACCESSORIES adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE CO-PILOT BLEEDBACK CONTROL VALVE (BBCV) WAS NOTED TO BE LEAKING AT THE SCREW (ROTATOR). 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 25111018 ↗
• 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 ↗
• MalfunctionJan 26, 2026Loose or Intermittent Connection

  IT WAS REPORTED THE COPILOT COULD NOT CONNECT TO THE THREE-WAY STOPCOCK BECAUSE THE SCREW THREAD OF THE COPILOT SIDE ARM WAS NOT CORRECT. ANOTHER COPILOT 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 24177332 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23822067 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23822002 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821511 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821381 ↗
• MalfunctionDec 10, 2025Loose or Intermittent Connection; Device Misassembled During Manufacturing /Shipping; Loose or Intermittent Connection; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT WHEN CONNECTING THE COPILOT BLEEDBACK CONTROL VALVE TO THE STOPCOCK, THERE WAS ALMOST NO THREADS ON THE SIDE PORT. A NEW COPILOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 23771366 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23605462 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23605388 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23605335 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23605261 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23605259 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23604526 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE COPILOTS WERE LEAKING DURING USE. 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 23604505 ↗

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