BD Insyte Autoguard 382533Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC PNK 20GA X 1.0IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Insyte Autoguard IV catheter from BD is a short-term tube placed in a vein. The FDA database holds 540 reports for it, many describing needles that do not pull back properly, leaks and contamination, with 18 injuries and no deaths. Two open recalls name this device, over tubing holes that can leak and needles that may not retract, which could lead to needlestick injuries and blood leaks.
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
- 527
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 527 adverse event reports that list this exact device (DI 00382903825332), received between Oct 18, 2017 and Sep 29, 2026 — classified as 16 injuries, 511 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (158 reports).
2 FDA recall records name this device's identifier, 2 still open.
9 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
- Jun 26, 2024Class IIOpen, Classified
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Z-2458-2024 · Root cause: Process control · Recall details · FDA record ↗
- Oct 4, 2023Class IIOpen, Classified
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
Z-0400-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem158
- Leak/Splash97
- Device Contamination with Chemical or Other Material84
- Fluid/Blood Leak39
- Defective Component23
- Break22
- Material Puncture/Hole21
- Material Split, Cut or Torn12
Patient problems
- No Clinical Signs, Symptoms or Conditions277
- No Known Impact Or Consequence To Patient129
- Insufficient Information44
- No Consequences Or Impact To Patient26
- Needle Stick/Puncture17
- No Information7
- No Patient Involvement7
- Discomfort5
Recent adverse event reports
The 25 most recent of 527 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Retraction Problem
Patient problems: Insufficient Information
MAUDE report 50935976 ↗MalfunctionSep 23, 2026Retraction Problem
It was reported that BD INSYTE AUTOG BC needle did not retract.Issue: A patient presented to IRU preoperatively for port placement. During peripheral IV insertion, a 20-gauge × 1-inch BD Insyte Autoguard BC catheter was used. After successful venipuncture, the white push-button mechanism designed to retract the needle did not function when activated. Additional information 14Sep2026:Can you please provide an exact date of event? 09SEP2026Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event. No injury or harm occurred to the patient or staff.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868156 ↗MalfunctionJun 29, 2026Premature Activation; Retraction Problem
DATE OF EVENT AND NUMBER OF OCCURRENCES 1/26/2026 PRODUCT DETAILS (MATERIAL AND LOT NUMBER) 5267705 DESCRIPTION OF THE ISSUE OBSERVED: NEEDLE RETRACTED PRIOR TO ACTIVATION PATIENT IMPACT (IF KNOWN) NONE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660772 ↗MalfunctionJun 24, 2026Leak/Splash
IT WAS REPORTED THAT BD INSYTE AUTOG BC LEAKED. BLOOD LEAKAGE AND HAVING TO STICK MULTIPLE TIMES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608397 ↗MalfunctionJun 17, 2026Nonstandard Device
VERBATIM: THE NEEDLE ITSELF IS SHARP BUT THE CATHETER ITSELF IS NOT SMOOTH AND MEETS RESISTANCE WHEN IT COMES IN CONTACT WITH THE SKIN. IT IS VERY PAINFUL FOR THE PATIENT. THE CATHETERS ITSELF IS WEAK AND BENDS EASILY. YOU CANNOT FLOAT THE CATHETER. WHEN A PATIENT IS A DIFFICULT STICK, YOU HAVE A VERY DIFFICULT TIME KNOWING IF YOU ARE IN THE VEIN. WHEN YOU START THE FLUIDS YOU WILL KNOW YOU ARE NOT IN WHEN YOU SEE THE INFILTRATE. IT IS DELAYS TIME WITH GETTING THE PATIENT READY. YOU HAVE TO USE MORE ACTUAL JELCOS OVERALL. YOU HAVE TO GIVE THE PATIENT AND ADDITIONAL STICK FOR ACCUCHECKS SINCE WE CAN NO LONGER USE THE HUB OF THE JELCO. SO WE ARE USING MORE PRODUCT AND IT IS AN ADDITIONAL STICK FOR THE PATIENT. IT IS ALSO MORE DIFFICULT TO DRAW LABS, YOU HAVE TO DO AN ADDITIONAL STICK AND USE ANOTHER PRODUCT TO DRAW.
Patient problems: Pain
MAUDE report 25540103 ↗MalfunctionJun 5, 2026Retraction Problem
" NURSE STARTED IV ON PATIENT, IV NEEDLE WOULD NOT RETRACT AFTER NURSE PUSHED "BUTTON". NO HARM TO PATIENT OR RN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416716 ↗MalfunctionMay 22, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT FULLY RETRACT. THE RN ENGAGED THE SAFETY MECHANISM ON THE PIV AND PROCEEDED TO DISPOSE OF THE DEVICE INTO THE SHARPS CONTAINER. WHILE HOLDING THE PIV VERTICALLY, SHE PLACED HER INDEX FINGER OVER THE OPENING WHERE THE NEEDLE RETRACTS INTO THE REAR OF THE DEVICE. AT THAT TIME, THE NURSE FELT A SLIGHT PRICK. UPON SQUEEZING HER FINGER, SHE OBSERVED A SMALL DROP OF BLOOD AT THE SITE.
Patient problems: Needle Stick/Puncture
MAUDE report 25257649 ↗MalfunctionApr 27, 2026Activation, Positioning or Separation Problem
IV NEEDLE SLOW TO RETRACT, ONLY FULLY RETRACTED ONCE REMOVED AFTER INSERTION. LOT #6020809 BD INSYTE AUTOGUARD BC. THE NEEDLE NOT RETRACTING POSES A SAFETY RISK TO THE USER. NO PATIENT HARM NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001581 ↗MalfunctionApr 22, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957647 ↗MalfunctionApr 22, 2026Retraction Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955887 ↗MalfunctionApr 14, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874274 ↗MalfunctionMar 30, 2026Retraction Problem
WE HAVE RECEIVED REPORTS IN REGARD TO THE BD INSYTE AUTOGUARD NEEDLES NOT RETRACTING. THE FDA ISSUED A RECALL, AND WE HAVE IDENTIFIED AN IMPACTED REF # THAT WAS NOT INCLUDED IN THE RECALL. VARIOUS REPORTS THAT THE NEEDLE DID NOT RETRACT FULLY AND HEALTH PROVIDERS WERE STRUCK. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE.
Patient problems: Insufficient Information; Needle Stick/Puncture; Perforation of Vessels
MAUDE report 24730799 ↗MalfunctionMar 30, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. NEEDLE POKED OUT OF CATHETER SORENESS TO ARM TRIED TO EXPLAIN TO NURSE AND CHARGE NURSE THAT SHEARING A CATHETER OCCURS WHEN THE CATHETER IS IN THE PATIENT AND THE NEEDLE IS PULLED BACK AND RE-ADVANCED. IF YOU WANT A BETTER-QUALITY PICTURE OF THE CATHETER, LET ME KNOW WHAT EMAIL ADDRESS AND I CAN EMAIL IT TO YOU.
Patient problems: Pain
MAUDE report 24722608 ↗MalfunctionMar 25, 2026
UPON STARTING IV, TECH NOTICED THERE WAS 'LEAKING' WITH THE SALINE FLUSH COMING FROM WHERE THE CATHETER MEETS THE PINK HUB OF THE IV. CONTINUAL LEAKING WAS WITNESSED AS SALINE WAS FLUSHED THROUGH. IV HAD TO BE REMOVED AND A NEW ONE STARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687188 ↗MalfunctionMar 16, 2026Retraction Problem; Activation Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604939 ↗MalfunctionMar 4, 2026Physical Resistance/Sticking
OUR INVESTIGATIONS TEAM RECEIVED ADDITIONAL SAMPLES INCLUDED WITH THE SAMPLE SHIPMENT RECEIVED FOR ANOTHER COMPLAINT. AT THE TIME THE ORIGINAL COMPLAINT WAS INITIALLY REPORTED, WE WERE NOT MADE AWARE OF ANY ISSUES ASSOCIATED WITH MATERIAL NUMBER. PER THE PREVIOUS COMPLAINT: IT WAS REPORTED BY CUSTOMER THAT THE BLOOD CONTROL FAILURE. AS NEEDLE IS RETRACTING IT PULLS THE CATHETER OUT. NURSES ARE HOLDING CATHETER TO KEEP IN PLACE.
Patient problems: Insufficient Information
MAUDE report 24507249 ↗MalfunctionFeb 27, 2026Retraction Problem
MalfunctionFeb 27, 2026Retraction Problem
MalfunctionFeb 27, 2026Retraction Problem
MalfunctionFeb 23, 2026Retraction Problem
CUSTOMER STATES THAT THEIR CUSTOMER HAD AN ISSUE WITH A BD CATHETER. THE BUTTON TO RETRACT THE NEEDLE IS NOT WORKING CORRECTLY. THE NEEDLE IS NOT RETRACTING AND IT SEEMS LIKE THE SPRING IS NOT WORKING. THEY HAD TO REMOVE THE NEEDLE/CATHETER AND STICK THE PATIENT AGAIN WITH A DIFFERENT CATHETER AND IT WORKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416044 ↗MalfunctionFeb 20, 2026Material Puncture/Hole; Activation, Positioning or Separation Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403563 ↗MalfunctionFeb 19, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388357 ↗MalfunctionFeb 19, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387921 ↗MalfunctionFeb 10, 2026Leak/Splash
OUR INVESTIGATIONS TEAM RECEIVED ADDITIONAL SAMPLES INCLUDED WITH THE SAMPLE SHIPMENT RECEIVED FOR ANOTHER COMPLAINT. AT THE TIME THE ORIGINAL COMPLAINT WAS INITIALLY REPORTED, WE WERE NOT MADE AWARE OF ANY ISSUES ASSOCIATED WITH MATERIAL NUMBER. PER THE PREVIOUS COMPLAINT: IT WAS REPORTED BY CUSTOMER THAT THE BLOOD CONTROL FAILURE. AS NEEDLE IS RETRACTING IT PULLS THE CATHETER OUT. NURSES ARE HOLDING CATHETER TO KEEP IN PLACE.
Patient problems: Insufficient Information
MAUDE report 24307460 ↗MalfunctionFeb 6, 2026Retraction Problem
ONE KNOWN INCIDENCE THAT NEEDLE WOULD NOT RETRACT. 3 FEB 2026 EVENT DATE CONFIRMATION REQUEST RESPONSE: CANNOT CONFIRM ALL OCCURRED ON (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279285 ↗
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-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-1999-2025 · May 21, 2025 · Open, ClassifiedREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/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-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-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-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-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
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 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 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 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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