BD Insyte Autoguard 381423Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD BL 22GA X 1.0IN · Class 2
All models of BD Insyte Autoguard (33)
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 IV catheter has 532 adverse event reports, with no deaths and 24 injuries. Most reports describe the safety needle failing to retract or retracting slowly, along with leaks of blood or fluid and frayed or broken catheters. One recall is open, begun in May 2025, because the needle may be slow to retract or fail to retract. Reports fell from 96 in the prior 12 months to 47 in the last 12 months.
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
- 528
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 528 adverse event reports that list this exact device (DI 00382903814237), received between Oct 30, 2017 and Sep 29, 2026 — classified as 25 injuries, 503 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (276 reports).
1 FDA recall record name this device's identifier, 1 still open.
10 other recalls cover devices cleared under the same FDA submission (K201075, K251654); 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 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-1999-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem276
- Leak/Splash81
- Device Contamination with Chemical or Other Material26
- Fluid/Blood Leak25
- Break21
- Defective Component19
- Material Puncture/Hole14
- Material Split, Cut or Torn14
Patient problems
- No Clinical Signs, Symptoms or Conditions369
- No Known Impact Or Consequence To Patient66
- Insufficient Information42
- No Consequences Or Impact To Patient23
- Needle Stick/Puncture12
- Foreign Body In Patient6
- Exposure to Body Fluids4
- Device Embedded In Tissue or Plaque3
Recent adverse event reports
The 25 most recent of 528 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50939012 ↗MalfunctionJun 25, 2026Material Frayed
IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER WAS FRAYED. 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 25626468 ↗MalfunctionJun 17, 2026Retraction Problem
RETRACTION ISSUES: ADDITIONAL INFORMATION: FURTHER DESCRIPTION: OUR RNS REPORT THAT THEY WILL GET FLASH BUT IT IS CATCHING AND PULLING OUT DURING RETRACTION. CUSTOMER RESPONDED ON JUN-04: WE HAD NO EMPLOYEE OR PATIENT INJURIES, HOWEVER, THE INCIDENT CAUSED APPREHENSION AMONG OUR IV PATIENTS, MAKING THEM RELUCTANT TO BE RESTUCK FOR SUBSEQUENT TREATMENT ATTEMPTS. SOME PATIENTS LEFT WITHOUT TREATMENT. THESE ARE USED IN OUR IV SPA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538310 ↗MalfunctionJun 17, 2026Retraction Problem
RETRACTION ISSUES: ADDITIONAL INFORMATION: FURTHER DESCRIPTION: OUR RNS REPORT THAT THEY WILL GET FLASH BUT IT IS CATCHING AND PULLING OUT DURING RETRACTION. CUSTOMER RESPONDED ON (B)(6): WE HAD NO EMPLOYEE OR PATIENT INJURIES, HOWEVER, THE INCIDENT CAUSED APPREHENSION AMONG OUR IV PATIENTS, MAKING THEM RELUCTANT TO BE RESTUCK FOR SUBSEQUENT TREATMENT ATTEMPTS. SOME PATIENTS LEFT WITHOUT TREATMENT. THESE ARE USED IN OUR IV SPA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538306 ↗MalfunctionJun 11, 2026Leak/Splash
THE CUSTOMER ADVISED THAT WHEN THE CATHETER IS INSERTED INTO THE PATIENT'S ARM, BLOOD BEGINS TO LEAK OUT OF THE SIDE OF THE CATHETER.
Patient problems: Insufficient Information
MAUDE report 25476403 ↗MalfunctionJun 5, 2026Retraction Problem
2GA IV CATHETER DID NOT RETRACT WHEN SAFETY WAS INITIATED. I HAD TO PULL IT OUT OF THE PATIENT AND THEN ATTEMPTED TO USE THE SAFETY RETRACT AND IT STILL WOULDN'T WORK. I ATTEMPTED TO ENGAGE THE SAFETY RETRACT A 3RD TIME AND IT WOULDN'T WORK.
Patient problems: Insufficient Information
MAUDE report 25409254 ↗MalfunctionMay 4, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. ONE NEEDLE WOULDN'T T RETRACT. INJURIES/ADVERSE EVENTS: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069918 ↗MalfunctionApr 20, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. INJURIES OR ADVERSE EVENT: NO. "PATIENT COMPLAINED OF PAIN WHEN RN WAS STARTING PATIENT IV. RN REMOVED IV AND FOUND THAT THE NEEDLE WAS STICKING OUT OF THE SIDE OF THE CATHETER INSTEAD OF OUT OF THE END.".
Patient problems: Pain
MAUDE report 24931840 ↗MalfunctionApr 14, 2026Material Frayed
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876758 ↗MalfunctionApr 14, 2026Material Frayed
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876745 ↗MalfunctionApr 14, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875265 ↗MalfunctionApr 10, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845752 ↗MalfunctionApr 9, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834687 ↗MalfunctionApr 6, 2026Activation, Positioning or Separation Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792781 ↗MalfunctionApr 6, 2026Activation, Positioning or Separation Problem; Material Integrity Problem
INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: PLASTIC HOUSING OVER THE NEEDLE IS NOT WORKING AS IT SHOULD. IT IS NOT RETRACTING CORRECTLY AND CAUSING ISSUES. ADDITIONAL INFORMATION: 3/30/2026: PLEASE CONFIRM IF THERE IS ANOTHER ISSUE OTHER THAN THE REPORTED RETRACTION FAILURE. IF YES, PROVIDE DETAILS. (NOT ANSWERED). DOES THE NEEDLE FAIL TO RETRACT? YES. IF YES, DOES THE NEEDLE PARTIALLY RETRACT, SLOWLY RETRACT, OR NOT RETRACT AT ALL? DID NOT RETRACT AT ALL. IS THERE ANY VISIBLE CATHETER DAMAGED WHEN IT APPEARS TO BE CAUGHT ON THE NEEDLE? NO. IS THERE ANY HARM/SERIOUS INJURY TO PATIENT? IT HAS CAUSED VEINS TO BE BLOWN BEFORE BUT NO SERIOUS HARM TO PATIENT. IF YES, PLEASE DESCRIBE IN DETAIL AND INCLUDE ANY TREATMENT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792778 ↗MalfunctionApr 6, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792458 ↗MalfunctionApr 6, 2026Retraction Problem
REPORTED ISSUES WITH THE INSYTE AUTOGUARD IV CATHETER LOT NUMBER: 5191871 EXP: 06/30/2028, ISSUES HAVE INCLUDED: NOT RETRACTING AFTER PUSHING THE BUTTON, RETRACTING BEFORE THE BUTTON IS PUSHED, AND IV CATHETER NOT ADVANCING AFTER NEEDLE HAS BEEN INTRODUCED. ADDITIONAL INFORMATION 4/1/2026: THERE WERE MULTIPLE REPORTS OF RETRACTING BEFORE THE BUTTON IS PUSHED, NOT RETRACTING AFTER PUSHING THE BUTTON. IT IS UNCLEAR IF THIS WAS EVENT DURING IV INSERTION OR WHEN THE DEVICE PACKAGE WAS OPENED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792445 ↗MalfunctionApr 1, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. AS THE NURSE WAS COMPLETING PLACING AN IV THE SAFETY BUTTON TO RETRACT THE NEEDLE WAS PRESSED AND THE NEEDLE DID NOT RETRACT. THE NURSE WAS ABLE TO PULL OUT THE NEEDLE MANUALLY AND THERE WAS NO IMPACT TO THE PATIENT OR THE EMPLOYEE. THE IV WAS SUCCESSFULLY STARTED. CUSTOMER RESPONSE ON MAR-27: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 09 FEB 2026 WHAT WAS THE IMPACT TO THE PATIENT? THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757473 ↗MalfunctionApr 1, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756573 ↗MalfunctionApr 1, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. IV NEEDLES NOT RETRACTING AS THEY SHOULD -THIS IS A MAJOR SAFETY ISSUE. ADDITIONAL INFORMATION RECEIVED 3/27/2026: WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? THE NEEDLE DID NOT RETRACT AT ALL WHEN THE BUTTON WAS PRESSED DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NO, IT DID NOT RETRACT AT ALL DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? NO, THE NEEDLE DID NOT RETRACT AT ALL. THE USED NEEDLE WAS COMPLETELY EXPOSED, CREATING A MAJOR SAFETY RISK FOR SHARPS EXPOSURE DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? THE NEEDLE DID NOT MOVE AT ALL WHEN THE BUTTON WAS PRESSED. DID THE BUTTON DEPRESS? NOT SURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756071 ↗MalfunctionMar 31, 2026
USED 22GA INSYTE AUTOGUARD IV CATHETER FOR PIV [PERIPHERAL IV] INSERTION. AFTER INSERT IV, TRIED TO RETRACT THE NEEDLE BUT WAS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741441 ↗MalfunctionMar 30, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE CATHETER. WE PURCHASE YOUR IV CATHETERS. WE OPENED ONE TO INSERT, ONLY TO FIND DEBRIS ON THE CATHETER. WHO CAN I TALK TO ABOUT THIS? ADDITIONAL INFORMATION RECEIVED ON 25MAR2026 CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? 03-19-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722789 ↗MalfunctionMar 5, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524737 ↗MalfunctionMar 4, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513915 ↗MalfunctionMar 4, 2026Retraction Problem
IT WAS REPORTED THAT THERE ARE ISSUES WITH RETRACTION. FAULTY NEEDLE RETRACTOR BUTTONS. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513774 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201075, K251654. One submission often covers many models, so check the product and lot details in each record.
- Z-2004-2025 · May 21, 2025 · Open, ClassifiedREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2007-2025 · May 21, 2025 · Open, ClassifiedREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Z-2001-2025 · May 21, 2025 · Open, ClassifiedREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
- Z-2000-2025 · May 21, 2025 · Open, ClassifiedREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
- Z-2003-2025 · May 21, 2025 · Open, ClassifiedREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2002-2025 · May 21, 2025 · Open, ClassifiedREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
- Z-2006-2025 · May 21, 2025 · Open, ClassifiedREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
- Z-2005-2025 · May 21, 2025 · Open, ClassifiedREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2458-2024 · Jun 26, 2024 · Open, ClassifiedBD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter
- Z-0400-2024 · Oct 4, 2023 · Open, ClassifiedBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
- BD Insyte Autoguard Shielded IV Catheter 381834Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days388 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 · 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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