BD Insyte Autoguard 382623Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC WING BLU 22GA X 1.0IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard IV catheter is a short-term catheter placed into a blood vessel. Its 92 reports, with 3 injuries and no deaths, often describe leaks at the insertion site or connection, the needle not retracting into its safety shield, and holes in the catheter. Several describe the needle piercing the catheter. No recalls name this device. Reports for the last 12 months (32) are more than in the previous 12 months (18).
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
- 91
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00382903826230), received between Oct 24, 2017 and Sep 29, 2026 — classified as 3 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (24 reports).
11 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
Most reported problems
Device problems
- Leak/Splash24
- Retraction Problem16
- Material Puncture/Hole11
- Fluid/Blood Leak7
- Material Integrity Problem7
- Break6
- Connection Problem6
- Device Contamination with Chemical or Other Material6
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Known Impact Or Consequence To Patient11
- Insufficient Information8
- No Consequences Or Impact To Patient6
- Bruise/Contusion2
- No Patient Involvement2
- Administration Site Reaction1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940848 ↗MalfunctionJul 1, 2026Material Puncture/Hole
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER HAS A HOLE IN IT. WE HAVE A LOT (#5188475) OF 22G CATHETERS THAT HAVE HOLES IN THEM. THE PATIENT'S BLOOD IS LEAKING OUT OF THE INSERTION SITE, HOWEVER, THE BLOOD CONTROL IS STILL IN TACT. SO THERE'S A HOLE IN THE TIP OF THE CATHETERS. CUSTOMER RESPONDED ON 17-JUN: THIS HAS HAPPENED ON MULTIPLE OCCASIONS, THE FIRST BEING (B)(6) 2026 AT 1000 AM. THE NEXT WAS MY COWORKER (B)(6) ON (B)(6) 2026, AND THE LAST ONE BEING (B)(6) 2026 WITH ME AGAIN. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2/3 PATIENTS WITH NEEDLE PHOBIA GOT FAINT AND LIGHTHEADED SEEING BLOOD RUN DOWN THEIR ARM OUT OF THE INSERTION SITE. AGAIN, THE BLOOD CONTROL IS INTACT, BUT THE LEAK APPEARED TO COME FROM A SMALL HOLE IN THE TIP OF THE PLASTIC CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682838 ↗MalfunctionJul 1, 2026Material Puncture/Hole
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER HAS A HOLE IN IT. WE HAVE A LOT (#5188475) OF 22G CATHETERS THAT HAVE HOLES IN THEM. THE PATIENT'S BLOOD IS LEAKING OUT OF THE INSERTION SITE, HOWEVER, THE BLOOD CONTROL IS STILL IN TACT. SO THERE'S A HOLE IN THE TIP OF THE CATHETERS. CUSTOMER RESPONDED ON 17-JUN THIS HAS HAPPENED ON MULTIPLE OCCASIONS, THE FIRST BEING (B)(6) 2026 AT 1000 AM. THE NEXT WAS MY COWORKER, (B)(6) ON (B)(6) 2026, AND THE LAST ONE BEING (B)(6) 2026 WITH ME AGAIN. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2/3 PATIENTS WITH NEEDLE PHOBIA GOT FAINT AND LIGHTHEADED SEEING BLOOD RUN DOWN THEIR ARM OUT OF THE INSERTION SITE. AGAIN, THE BLOOD CONTROL IS INTACT, BUT THE LEAK APPEARED TO COME FROM A SMALL HOLE IN THE TIP OF THE PLASTIC CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682833 ↗MalfunctionJun 22, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. THE PATIENT WASN'T OVERTLY HARMED, THANKFULLY. HOWEVER, THE PATIENT DID RECEIVE AN ADDITIONAL IV STICK THAT WAS NOT NECESSARY DUE TO THE POOR QUALITY OF THE NEEDLE. IN THIS CASE, THE NEEDLE WAS NOT ONLY BLUNT-TIPPED, BUT IT WAS NOT ALIGNED PROPERLY WITH THE CATHETER AND PUNCTURED THROUGH THE CATHETER ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25577761 ↗MalfunctionMay 28, 2026Leak/Splash; Incomplete or Inadequate Connection
WHEN NS FLUSH WAS CONNECTED TO IV CATHLON, THERE WAS LEAKAGE AT THE CONNECTION SITE. ATTEMPTED TO DISCONNECT AND RE-CONNECT BUT WAS UNABLE TO HAVE SEALED CONNECTION WHEN PUSHING FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323313 ↗MalfunctionMay 27, 2026Retraction Problem; Difficult to Advance
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE BD 22G INSYTE AUTOGUARD IV HAS DIFFICULTY RETRACTING NEEDLE TO INITIATE SAFETY. THERE WAS NO HARM TO THE PATIENT OR CLINICIAN OTHER THAN HAVING TO RESTART THE IV. 5/20/2026: PREVIOUSLY, NONE OF THE CATHETERS WERE PIERCED BY THE NEEDLE. AS TO THE SECOND QUESTION, I AM UNABLE TO ANSWER THAT. I WAS NOT THE ONE WHO UTILIZED THE PART AND HE DOES NOT REMEMBER. WE USE SO MANY OF THESE EACH DAY. EVERYTHING DURING THE VENIPUNCTURE PROCESS WENT SMOOTHLY, THOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303209 ↗MalfunctionMay 27, 2026Retraction Problem; Difficult to Advance
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE BD 22G INSYTE AUTOGUARD IV HAS DIFFICULTY RETRACTING NEEDLE TO INITIATE SAFETY. THERE WAS NO HARM TO THE PATIENT OR CLINICIAN OTHER THAN HAVING TO RESTART THE IV. 5/20/2026: PREVIOUSLY, NONE OF THE CATHETERS WERE PIERCED BY THE NEEDLE. AS TO THE SECOND QUESTION, I AM UNABLE TO ANSWER THAT. I WAS NOT THE ONE WHO UTILIZED THE PART AND HE DOES NOT REMEMBER. WE USE SO MANY OF THESE EACH DAY. EVERYTHING DURING THE VENIPUNCTURE PROCESS WENT SMOOTHLY, THOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303201 ↗MalfunctionApr 22, 2026Material Perforation; Material Integrity Problem
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) WAS INSERTING BD 22G INSYTE AUTOGUARD BC WINGED IV CATHETER. IT WAS REPORTED THAT THE NEEDLE "SPLIT" THE CATHETER. UPON GEMBA WALK INSPECTION THE NURSE HAD RETRACTED THE NEEDLE AND DISPOSED OF THE NEEDLE DEVICE, LEAVING ONLY THE PLASTIC CATHETER FOR INSPECTION AFTER TAKING PHOTOS OF THE DEVICE. IT APPEARED THE NEEDLE HAD PUNCTURED THE SIDE OF THE CATHETER, RATHER THAN SPLIT IT. NURSE DENIED MANIPULATING THE NEEDLE DURING INSERTION. NO HARM TO PATIENT, SMALL BRUISE FROM BLOWN SITE.
Patient problems: Ecchymosis; Perforation of Vessels
MAUDE report 24955739 ↗MalfunctionApr 22, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955255 ↗MalfunctionApr 14, 2026Leak/Splash; Connection Problem
IT WAS REPORTED THAT THERE WERE CONNECTION ISSUES THAT LED TO LEAKAGE. WE HAVE BEEN HAVING DIFFICULTY WITH THE CONNECTION BETWEEN THE IV CATHETER AND THE SALINE LOCK SEATING PROPERLY AND LEAKING. THEY HAVE EITHER HAD TO REALLY FORCE IT TOGETHER OR RESTART THE PATIENT'S IV; THIS HAS HAPPENED ABOUT A HALF A DOZEN TIMES IN THE LAST COUPLE OF DAYS AND ADDITIONAL TIMES IN THE LAST FEW WEEKS. ADDITIONAL INFORMATION 4/3/2026: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? DATES STARTING (B)(6) 2026 (ISSUE OF MULTIPLE OCCURRENCES REPORTED ON (B)(6) 2026 AND LOT WAS ABLE TO BE REPLACED 3/30/26). WHAT WAS THE IMPACT TO THE PATIENT? FOR THE MOST PART, THE CONNECT WOULD LEAK SLIGHTLY AND FORCIBLY TIGHTENED TO MINIMIZE THE LEAK. ON ONE OCCASION, THE IV COULD NOT BE SALVAGED AND NEEDED TO BE RESTARTED DUE TO THE CATHETER CONNECTION LEAK NOT BEING ABLE TO BE MANAGED. YOU MENTIONED THAT THIS ISSUE HAS OCCURRED APPROXIMATELY HALF A DOZEN TIMES OVER THE PAST COUPLE OF DAYS, AS WELL AS ADDITIONAL TIMES IN THE PAST FEW WEEKS. IF SO, COULD YOU PLEASE PROVIDE THE DATE OF EACH OCCURRENCE, INDICATE WHETHER THERE WAS ANY PATIENT IMPACT, AND ADVISE WHETHER THE ISSUE OCCURRED WITH ANY OTHER LOT NUMBERS? ISSU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875266 ↗MalfunctionApr 10, 2026Leak/Splash; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844281 ↗MalfunctionApr 6, 2026Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793123 ↗MalfunctionApr 2, 2026Product Quality Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767370 ↗MalfunctionMar 30, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736280 ↗MalfunctionMar 30, 2026Leak/Splash; Connection Problem
MalfunctionMar 30, 2026Leak/Splash; Connection Problem
MalfunctionMar 30, 2026Leak/Splash; Connection Problem
IT WAS REPORTED THAT LEAKAGE AT LUER CONNECTION OCCURRED. "BAD CONNECTION BETWEEN THE CATHETER AND THE TUBING. IT WOULD NOT CONNECT COMPLETELY, AND IT WOULD LEAK FLUIDS." "LEAKING IV CONTRIBUTING TO INADEQUATE DELIVERY OF MEDICATION/FLUIDS, ADDITIONAL STICKS TO PATIENT, AND MORE SLOWING OF WORKFLOW FOR CLINICIAN".
Patient problems: Insufficient Information
MAUDE report 24729958 ↗MalfunctionMar 25, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689666 ↗MalfunctionMar 17, 2026
CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) WAS INSERTING BD 22G INSYTE AUTOGUARD BC WINGED IV CATHETER. IT WAS REPORTED THAT THE NEEDLE "SPLIT" THE CATHETER. UPON GEMBA WALK INSPECTION THE NURSE HAD RETRACTED THE NEEDLE AND DISPOSED OF THE NEEDLE DEVICE, LEAVING ONLY THE PLASTIC CATHETER FOR INSPECTION AFTER TAKING PHOTOS OF THE DEVICE. IT APPEARED THE NEEDLE HAD PUNCTURED THE SIDE OF THE CATHETER, RATHER THAN SPLIT IT. NURSE DENIED MANIPULATING THE NEEDLE DURING INSERTION. NO HARM TO PATIENT, SMALL BRUISE FROM BLOWN SITE.
Patient problems: Bruise/Contusion
MAUDE report 24617060 ↗MalfunctionJan 22, 2026Leak/Splash; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24153399 ↗MalfunctionNov 26, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656011 ↗MalfunctionNov 26, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653639 ↗MalfunctionNov 26, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653638 ↗MalfunctionNov 26, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653637 ↗MalfunctionNov 26, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653630 ↗
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-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-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-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-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-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-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-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-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-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 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
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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