BD Insyte Autoguard 381412Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD YEL 24GA X .75IN · 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 placed in a blood vessel. Many of the 301 reports describe the safety needle not retracting, fluid leaks or splashes, and catheters splitting or fraying. The reports include 8 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
- 294
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 00382903814121), received between Jan 11, 2018 and Jun 24, 2026 — classified as 8 injuries, 286 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (119 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
- Retraction Problem119
- Leak/Splash58
- Material Split, Cut or Torn28
- Fluid/Blood Leak19
- Break16
- Device Contamination with Chemical or Other Material15
- Material Puncture/Hole14
- Defective Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Known Impact Or Consequence To Patient60
- No Consequences Or Impact To Patient22
- Insufficient Information19
- Needle Stick/Puncture7
- Foreign Body In Patient5
- Discomfort4
- Pain4
Recent adverse event reports
The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Material Integrity Problem
IT WAS REPORTED THAT INSYTE AUTOGUARD CATHETER FRAYED. RN ATTEMPTED PIV [PERIPHERAL IV] INSERTION; CATHETER FRAYED DURING INSERTION. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25613900 ↗MalfunctionJun 23, 2026Material Puncture/Hole
IT WAS REPORTED THAT INSYTE AUTOGUARD CATHETER TIP DAMAGED. RN WAS PLACING A NEW PIC ON A PATIENT AND WHEN RN TOOK THE CAP OFF THE CATHETER THE TIP WAS ALREADY SHEERED HALFWAY OFF. THE MALFUNCTIONED CATHETER WAS DISCARDED, AND A NEW ONE WAS OBTAINED TO PLACE PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598069 ↗MalfunctionJun 17, 2026Retraction Problem
MULTIPLE STAFF ARE REPORTING THAT THE NEEDLE IS RETRACTING WHEN REMOVING THE CAP. STAFF RELATE THAT THEY ARE NOT INADVERTENTLY SQUEEZING THE BUTTON WHEN REMOVING THE CAP. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE REPORTED. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 3/17/2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534538 ↗MalfunctionJun 11, 2026Break; Nonstandard Device
WE HAVE BEEN HAVING TROUBLE WITH FLIMSY 24-GAUGE NEEDLES. TODAY WE CAME ACROSS THIS NEEDLE WHERE THE END OF THE BEVEL BROKE RIGHT OFF AND COULD HAVE EASILY GONE INTO THE PATIENT. LUCKILY, WE PULLED THE NEEDLE OUT AFTER NOT BEING ABLE TO OBTAIN AN IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476963 ↗MalfunctionApr 30, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE CUSTOMER ADVISED THAT THE NEEDLE WILL NOT RETRACT ONCE THE CATHETER WAS PLACED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044825 ↗MalfunctionApr 16, 2026Material Frayed
IT WAS REPORTED THAT THE CATHETER FRAYED. RN ATTEMPTED PIV INSERTION: CATHETER FRAYED DURING INSERTION. CATHETER WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO HARM TO PATIENT NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900022 ↗MalfunctionApr 16, 2026Material Frayed; Leak/Splash
RN WAS ATTEMPTING TO PLACE A PIV ON THIS PATIENT IN THE LEFT HAND. SHE WAS ABLE TO GET THE IV IN PLACE, HOWEVER, THEN THE IV SITE STARTED LEAKING WITH THE NEEDLE NOT RETRACTED YET FROM THE CATHETER. SHE REMOVED THE IV AND NOTED THAT THE TIP OF THE CATHETER WAS FRAYED. NO INFILTRATION OR EXTRAVASATION NOTED FOR THIS PIV ATTEMPT. CHARGE RN NOTIFIED AND MADE AWARE OF EQUIPMENT ISSUE. THE IV WAS PUT IN A BIOHAZARD BAG ALONG WITH THE PACKAGE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899357 ↗MalfunctionApr 16, 2026Material Puncture/Hole
RN WAS ABOUT TO START IV ON PATIENT'S RIGHT HAND USING 24G INSYTE AUTOGUARD IV CATHETER. ON NEEDLE INSERTION, FLASH WAS SEEN AND RN STARTED TO ADVANCE CATHETER WHEN RESISTANCE WAS FELT AND PATIENT GRIMACED IN PAIN. IV CATHETER WAS REMOVED AND GAUZE AND COBAN APPLIED ON INSERTION SITE. ON INSPECTION OF IV CATHETER, PART OF THE CATHETER WAS BENT AT THE TIP AND NEEDLE SEEMED TO HAVE PUNCTURED THROUGH IT HENCE UNABLE TO ADVANCE CATHETER INTO PATIENT'S VEIN. NEW IV ACCESS ESTABLISHED ON LEFT HAND WHICH WAS SUCCESSFUL. TREATMENT PROCEEDED AS ORDERED. PATIENT WAS DISCHARGED IN STABLE CONDITION WAS THERE INJURY? RESULTED IN THE NEED FOR INCREASED MONITORING.
Patient problems: Pain
MAUDE report 24897425 ↗MalfunctionApr 11, 2026Material Frayed
IT WAS REPORTED THAT THE CATHETER WAS FRAYING. FROM THE INITIAL REVIEW, THE PRIMARY CONCERN APPEARS TO BE CATHETER FRAYING DURING INSERTION REQUIRING REMOVAL AFTER PATIENT CONTACT. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846269 ↗MalfunctionApr 1, 2026Material Integrity Problem
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. RN WAS ACCESSING PATIENT WITH A 24 G INSYTE DURING THIS THE CATHETER SPLIT FORM THE NEEDLE INSIDE PATIENTS' VEIN, WHEN RN REMOVED NEEDLE, IT HAD RIPPED THROUGH PLASTIC ON CATHETER. REPORT JUST SAYS THERE WAS HARM TO THE PATIENT. ADDITIONAL INFORMATION 3/30/2031: I DO NOT KNOW THE EXTENT OF THE PATIENT IMPACT AS THOSE DETAILS ARE KEPT SECURE, BUT THAT THERE WAS SOME PATIENT HARM WITH WHAT HAPPENED.
Patient problems: Insufficient Information
MAUDE report 24757936 ↗MalfunctionMar 26, 2026
RN WAS ACCESSING PATIENT WITH A 24 G INSYTE; DURING THIS, THE CATHETER SPLIT FROM THE NEEDLE INSIDE PATIENTS' VEIN, WHEN RN REMOVED NEEDLE, IT HAD RIPPED THROUGH PLASTIC ON CATHETER.
Patient problems: Insufficient Information
MAUDE report 24701181 ↗MalfunctionMar 12, 2026Material Perforation
MalfunctionMar 10, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562444 ↗MalfunctionMar 10, 2026Leak/Splash
WHEN THE J-LOOP WAS CONNECTED TO THE 24-GAGE CATHETER IT LEAKED WHEN FLUSHED ADDITIONAL INFORMATION 3/9/26: THERE WAS NO SERIOUS INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559254 ↗MalfunctionMar 9, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552597 ↗MalfunctionMar 9, 2026Leak/Splash
WHEN THE J-LOOP WAS CONNECTED TO THE 24-GAGE CATHETER IT LEAKED WHEN FLUSHED. ADDITIONAL INFORMATION 3/4/26: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE KNOWN. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 01-29-2026 WE HAD A SECOND EVENT AS WELL, SO I AM NOT 100% SURE WHICH ONE THIS IS REFERENCING. THE OTHER EVENT DATE IS 10-20-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552590 ↗MalfunctionMar 9, 2026Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER SHREDDED. I INSERTED THE CATHETER AND NEEDLE AND IMMEDIATELY THE SKIN STARTED TO BLEED AT THE INSERTION SITE. I PULLED OUT THE CATHETER, RETRACTED THE NEEDLE, AND NOTICED THE CATHETER HAD SHREDDED. WAS THERE INJURY? YES. ADDITIONAL INFORMATION RECEIVED 3/6/26: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS: NO ADVERSE EVENTS OR SERIOUS INJURY TO CAREGIVER OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546296 ↗MalfunctionFeb 20, 2026Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401045 ↗MalfunctionJan 29, 2026Material Split, Cut or Torn
EVENT 1 OF 2 THE IV WAS SPLICING OR SHEERING DUE INSERTION OF IV AFTER REPOSITIONING DURING INSERTION. SEE RESPONSE FROM CUSTOMER BELOW. THE ISSUE HAPPENED DURING REPOSITING, AFTER INSERTED AND PULLING BACK THE NEEDLE BROKE THROUGH THE CATHETER. THIS INCIDENT IS A RECENT OCCURRENCE AND HAS HAPPENED TWICE. CLARIFICATION RECEIVED 1/21/2026: NO PATIENT HARM JUST PAINFUL.
Patient problems: Pain
MAUDE report 24216623 ↗MalfunctionJan 29, 2026Material Split, Cut or Torn
EVENT 2 OF 2. THE IV WAS SPLICING OR SHEERING DUE INSERTION OF IV AFTER REPOSITIONING DURING INSERTION. SEE RESPONSE FROM CUSTOMER BELOW. THE ISSUE HAPPENED DURING REPOSITING, AFTER INSERTED AND PULLING BACK THE NEEDLE BROKE THROUGH THE CATHETER. THIS INCIDENT IS A RECENT OCCURRENCE AND HAS HAPPENED TWICE. CLARIFICATION RECEIVED 1/21/2026: NO PATIENT HARM JUST PAINFUL.
Patient problems: Pain
MAUDE report 24216618 ↗MalfunctionJan 29, 2026Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211303 ↗MalfunctionJan 29, 2026Leak/Splash; Connection Problem
THE HUB ON THE IV CATHETER DOES NOT FIT WELL ON THE TUBING AND EVEN AFTER TRYING TO TIGHTEN, IT LEAKS SIGNIFICANTLY. WE TRIED A DIFFERENT TUBING AND IT STILL LEAKED. AN ADDITIONAL STICK HAD TO BE DONE TO START A NEW IV. SO THE PATIENTS HAD TO BE STUCK MULTIPLE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211290 ↗MalfunctionJan 22, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151678 ↗MalfunctionJan 14, 2026Material Split, Cut or Torn
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073944 ↗MalfunctionJan 2, 2026Material Split, Cut or Torn
THE PLASTIC CATHETER WAS SPLIT AND FLARED AT THE END. THIS DEFECT PREVENTED THE CATHETER FROM BEING THREADED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23948322 ↗
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-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-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-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-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-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-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-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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