Insyte Autoguard 381923Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ Winged Shielded IV Catheter 22 GA x 1.00 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Insyte Autoguard winged IV catheter is a short-term intravenous line used for blood draws and infusions. Most of the 26 reports describe the protective needle mechanism not retracting properly — sticking partway, delaying or failing to pull back — and a few mention a frayed or squared-off catheter tip, air in the device, or a hole in the material. No deaths and no injuries were reported. There is 1 open recall, started in May 2025, because the needle may retract slowly or not at all.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382903819232), received between Jul 10, 2019 and Jun 8, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (14 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- May 21, 2025Class IIOpen, Classified
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2006-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem14
- Air/Gas in Device2
- Defective Component2
- Activation Problem1
- Break1
- Contamination1
- Material Integrity Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information3
- Anxiety1
- Exposure to Body Fluids1
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026
RN WENT TO START PIV WITH 22G PIV NEEDLE/CATHETER, THE NEEDLE BARELY PENETRATED THE SKIN AND THE CATHETER WOULD NOT GO INTO THE SKIN. THIS RN RETRACTED THE NEEDLE TO DISCOVER THE CATHETER WAS FRAYED AND SQUARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425926 ↗MalfunctionMay 29, 2026Mechanical Problem
IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE ROLLER CLAMP ON THE IV ADMINISTRATION SET IS DIFFICULT TO ADJUST DRIP RATE, AND IT IS LEAVING MARKS ON THE IV TUBING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326816 ↗MalfunctionApr 16, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETERACT. DURING USE OF INSYTE AUTOGUARD, A DELAY IN NEEDLE RETRACTION WAS OBSERVED AFTER ACTIVATION OF THE SAFETY MECHANISM WHEN THE WHITE BUTTON WAS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895774 ↗MalfunctionDec 5, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730144 ↗MalfunctionDec 4, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn
MalfunctionAug 28, 2025Retraction Problem; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD INSIDE THE IV INSERTION KIT ISSUED IN AHMC HAS BEEN REPORTED HAVING A DEFECT WHILE THEY PUSH THE BUTTON FOR NEEDLE ENCAPSULATION OF THE CATHETER. THEY HAVE MENTIONED THAT THEY HAVE A HARD TIME USING IT AS IT DELAYS NEEDLE ENCAPSULATION WHICH MAKES THE BUTTON HARDER TO PRESS DURING INSERTION. NO HARM/SERIOUS INJURY TO PATIENT/HCP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911954 ↗MalfunctionJul 3, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD INSIDE THE IV INSERTION KIT ISSUED IN AHMC HAS BEEN REPORTED HAVING A DEFECT WHILE THEY PUSH THE BUTTON FOR NEEDLE ENCAPSULATION OF THE CATHETER. THEY HAVE MENTIONED THAT THEY HAVE A HARD TIME USING IT AS IT DELAYS NEEDLE ENCAPSULATION WHICH MAKES THE BUTTON HARDER TO PRESS DURING INSERTION. (B)(6) 2025 IT WAS DETECTED AFTER USE ONCE THE BUTTON WAS PRESSED FOR ENCAPSULATION. NO PATIENT WAS IMPACTED, BUT THE NURSES FROM DIFFERENT DEPARTMENTS ALREADY RAISED SAME CONCERN FROM THE ACCOUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395480 ↗MalfunctionJun 12, 2025Retraction Problem; Retraction Problem
CLARIFYING INFORMATION RECEIVED: 1-JUL-25 ¿ COMPLAINT TO BE CANCELLED. NOT A COMPLAINT FROM A CUSTOMER. THE SALES REP ONLY SHARES THE RECENT FIELD ACTION MDS_25_5274 AS IT SUSPECTED COMPLAINT *** WAS RELATED TO THIS FSCA. INTAKE TEAM ERRONEOUSLY CREATED 3 NEW COMPLAINTS BASED ON THE BD FIELD ACTION DOCUMENT.
Patient problems: Insufficient Information
MAUDE report 22197097 ↗MalfunctionJun 12, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD HAS DETERMINED THAT WHEN INSERTING THE CATHETER, THE NEEDLE RETRACTS SLOWLY OR DOES NOT RETRACT AT ALL. SLOW OR NO RETRACTION MAY RESULT IN REPEATED ATTEMPTS TO RETRACT THE NEEDLE BY PRESSING THE BUTTON. IT IS ALSO POSSIBLE THAT A NEEDLE MAY REMAIN EXPOSED DESPITE ATTEMPTS TO COVER IT.
Patient problems: Insufficient Information
MAUDE report 22196597 ↗MalfunctionApr 30, 2025Break; Material Integrity Problem; Air/Gas in Device; Break; Material Integrity Problem; Air/Gas in Device
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936070 ↗MalfunctionMar 10, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON. INCIDENT DETAILS: WHEN STARTING AN IV WITH THE 22GA ANGIOCATHS, THE NEEDLE DOES NOT RETRACT WHEN THE BUTTON IS PRESSED AND/OR THERE IS A DELAY IN THE RETRACTION OF THE NEEDLE. FREQUENCY OF PROBLEM: MULTIPLE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21565174 ↗MalfunctionMar 10, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21565151 ↗MalfunctionFeb 26, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21473231 ↗MalfunctionFeb 26, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21473222 ↗MalfunctionFeb 20, 2025Retraction Problem; Retraction Problem
MalfunctionFeb 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CATHETER NEEDLE DOES NOT RETRACT, RESULTING IN RISK OF NEEDLESTICK INJURY TO CAREGIVER. RESPONSE RECEIVED ON 07-02-2025: WAS THE DEVICE BEING USED ON THE PATIENT WHEN THE PROBLEM OCCURRED? YES. SEVERAL TIMES HAS THE PATIENT OR USER BEEN HARMED? YES IF YES, PLEASE EXPLAIN SPLASHING BLOOD ON THE CAREGIVER AND APPREHENSION VERY IMPORTANT TO USE DID THE MALFUNCTION CAUSE A NEEDLESTICK INJURY TO THE HEALTHCARE STAFF OR THE PATIENT? NO NEEDLE.
Patient problems: Anxiety; Exposure to Body Fluids
MAUDE report 21394845 ↗MalfunctionDec 26, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFICULTY RETRACTING THE CANULA. RECURRENT PROBLEMS WITH SEVERAL CAREGIVERS. LETTER ATTACHED. PROBLEM RETRACTING THE CANULA. PRESSED 2 TIMES. REPEATED INCIDENTS WITH SEVERAL IDES NONE BUT RISK OF AES CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? YES, 1 UNIT USED (DURING OR AFTER USE) IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21022126 ↗MalfunctionDec 4, 2024Premature Separation; Premature Separation
ADDITIONAL INFO RECEIVED. DEC 02.2024 WE HAVE CONTINUED TO RECEIVE NEGATIVE FEEDBACK, EVEN TODAY. THIS FEEDBACK HAS IN FACT HAD AN IMPACT ON THE BUSINESS PROCESS, REQUIRING MULTIPLE PUNCTURES DUE TO FAILURE ON THE FIRST ATTEMPT: LONG DEVICE LENGTH, MAKING PUNCTURE DIFFICULT, ESPECIALLY IN THE JUGULAR; DIFFICULTY IN INSERTING THE CATHETER BECAUSE IT IS NOT VERY SHARP, EVEN WITH THE PROPER PUNCTURE TECHNIQUE WITH BEVEL DIRECTION; UNSATISFACTORY BLOOD RETURN TO CERTIFY THE SUCCESS OF THE PUNCTURE - FROSTED CANNON; SHORT CATHETER, NOT FAVORING PUNCTURE IN OBESE PATIENTS WITH DEEPER VEINS. WE UNDERSTAND AND RECOGNIZE THE BENEFITS OF THE PRODUCT IN TERMS OF THE ACTIVE ACTIVATION OF THE SAFETY DEVICE (REDUCING THE RISK OF A PUNCTURE ACCIDENT) AND THE FACT THAT IT WAS DEVELOPED WITH TEFLON (A RADIOACTIVE AND BIOCOMPATIBLE MATERIAL). HOWEVER, WE ARE FACING A NUMBER OF CHALLENGES BECAUSE IT DOESN'T ALLOW THE PROFESSIONAL TO PERFORM THE PUNCTURE BETTER, IT ISN'T EASY TO HANDLE AND IT HAS AN IMPACT ON THE SUCCESS OF THE FIRST PUNCTURE, CAUSING PATIENTS TO UNDERGO MULTIPLE PUNCTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849239 ↗MalfunctionDec 4, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED CATHETER TIP DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: NEEDLE TOO FAR FROM THE START OF THE CATHETER. ELDERLY PATIENTS WITH BALLERINA VEINS FIND CATHETER PROGRESSION MORE CHALLENGING. NEEDLE RETRACTS TOO QUICKLY, SOMETIMES SPLASHING BLOOD DISTANCE FROM NEEDLE TO START OF CATHETER. SENSATION OF PUSHING THE VEIN WITHOUT CUTTING BLUNT TIP. BAD CUTTING SENSATION PAINFUL FOR PATIENT. PATIENTS WITH MORE RESISTANT SKIN NEEDLE GUARD TOO LONG, MAKING IT DIFFICULT TO GRIP NO PROBLEMS IN GENERAL, BUT NOT YOUR PREFERENCE -POOR GRIP DUE TO SIZE. THE CATHETER GRINDS VERY WELL AND SLIDES WELL SAFETY TRIGGER TOO FAST, SOMETIMES SPLASHES OR IS TRIGGERED UNINTENTIONALLY REPORTS SOME ADVANTAGES AND DISADVANTAGES SOMEWHAT BLIND CATHETER. I MISSED THE BLOOD RETURN ON THE CANNON DIFFICULT TO GRIP. NEEDLE SLIPS OUT OF THE CATHETER IF YOU DON'T HOLD THE FLAP NEEDLE TIGHTER IN THE POLYURETHANE OF THE CATHETER USED BEFORE, THE BD'S NEEDLE SLIPS OUT VERY EASILY. REGARDING THE DISTANCE BETWEEN THE NEEDLE AND THE CATHETER, THEY REPORT THAT MANY TIMES WHEN THEY NOTICE THE BLOOD RETURN THROUGH TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849125 ↗MalfunctionDec 3, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20836185 ↗MalfunctionOct 29, 2024Contamination; Contamination
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560512 ↗MalfunctionMay 8, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271989 ↗MalfunctionMar 29, 2024Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE RETRACTION BUTTON DID NOT DEPRESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT SAFETY MECHANISM PUSH BUTTON CANNOT BE PRESSED DURING USE. CUSTOMER REPORTED THAT WHEN PLACING AN INDWELLING NEEDLE IN A PATIENT, THE PUSH BUTTON WAS STIFF AND I COULDN'T PRESS IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004131 ↗MalfunctionSep 15, 2023Air/Gas in Device; Air/Gas in Device
THIS REPORT IS ABOUT CONNECTION FAILURE. WHEN BLOOD WAS COLLECTED WITH A SYRINGE, AIR CAME IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17752981 ↗MalfunctionJul 10, 2019Retraction Problem; Retraction Problem
IT HAS BEEN REPORTED THAT ONE 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD HAS EXPERIENCED NEEDLE RETRACTION FAILURE AND A NEEDLE STICK INJURY AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ACTIVATION BUTTON DID NOT WORK. AFTER INSERTING IV CATHETER USING INSYTE AUTOGUARD, ACTIVATION BUTTON DID NOT RETRACT THE NEEDLE CAUSING THE NURSE ON DUTY GET PRICK HIM. ACTIVATION OF SAFETY FEATURE OF INSYTE AUTOGUARD DID NOT WORK AFTER INSERTING THE CATHETER.
Patient problems: Needle Stick/Puncture
MAUDE report 8777546 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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