ACCESSORIES 1003330Recalls & reported problems
Abbott Vascular Inc. · COPILOT Kit includes Bleedback Control Valve / Guide Wire Introducer / Torque Device · Class 2
All models of ACCESSORIES (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Abbott Vascular COPILOT kit is a guide wire accessory set with a bleedback control valve used to connect to a stopcock during procedures like coronary artery work. The 72 reports mostly describe fluid leaking or splashing from the valve and threads that do not screw on properly, so it cannot be connected and another device is used to finish the procedure. There are 2 reports of injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 08717648013980), received between Nov 9, 2016 and May 7, 2026 — classified as 2 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (57 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash57
- Loose or Intermittent Connection19
- Unstable2
- Break1
- Device Misassembled During Manufacturing /Shipping1
- Device Operates Differently Than Expected1
- Difficult to Insert1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient7
- No Patient Involvement5
- Low Blood Pressure/ Hypotension2
Recent adverse event reports
The 25 most recent of 72 reports, 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 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 ↗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 23604301 ↗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 23604209 ↗MalfunctionNov 19, 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 23597815 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE COPILOT DEVICE WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, FLUID WAS NOTED TO BE LEAKING OUT OF THE COPILOT CAP. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER COPILOT TO CONTINUE THE PROCEDURE. 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 23378465 ↗MalfunctionOct 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE COPILOT DEVICE WAS LEAKING FROM THE CAP DURING THE PROCEDURE; HOWEVER, THE COPILOT DEVICE WAS ABLE TO BE USED SUCCESSFULLY IN THE PROCEDURE. 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 23312758 ↗MalfunctionOct 15, 2025Leak/Splash; Leak/Splash
SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, RETURNED DEVICE ANALYSIS OBSERVED THAT THERE WAS NO LEAK NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292964 ↗MalfunctionSep 17, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING USE OF THREE COPILOT DEVICES, THE ROTATOR WAS LOOSE AND COULD NOT CONNECT TO ANOTHER DEVICE. THE COPILOT DEVICES WERE REPLACED WITH HEMOSTATIC VALVES OF DIFFERENT BRANDS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 23072465 ↗MalfunctionSep 17, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING USE OF THREE COPILOT DEVICES, THE ROTATOR WAS LOOSE AND COULD NOT CONNECT TO ANOTHER DEVICE. THE COPILOT DEVICES WERE REPLACED WITH HEMOSTATIC VALVES OF DIFFERENT BRANDS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 23072462 ↗MalfunctionSep 17, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING USE OF THREE COPILOT DEVICES, THE ROTATOR WAS LOOSE AND COULD NOT CONNECT TO ANOTHER DEVICE. THE COPILOT DEVICES WERE REPLACED WITH HEMOSTATIC VALVES OF DIFFERENT BRANDS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 23072459 ↗MalfunctionAug 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CORONARY ARTERY. A GUIDEWIRE INTRODUCER WAS USED TO ASSIST IN ADVANCING THE GUIDE WIRE AND BALLOON TO THE LESION SITE. AFTER CONNECTING THE GUIDE WIRE INTRODUCER TO THE COPILOT, CONTINUOUS EXTERNAL BLOOD LEAKAGE FROM THE VALVE WAS OBSERVED, RENDERING IT UNUSABLE. A NEW HEMOSTASIS VALVE WAS IMMEDIATELY REPLACED TO CONTINUE THE PROCEDURE. THIS INCIDENT PROLONGED THE PROCEDURE TIME HOWEVER AS THERE WAS NO ADVERSE PATIENT EFFECT THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860365 ↗MalfunctionJun 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS UNKNOWN ARTERY. TWO GUIDEWIRE ACCESSORY KITS COPILOTS WERE NOTED TO LEAK BACK AND NOTED TO BE USED THROUGHOUT 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 22144230 ↗
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 · TerminatedAbbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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