BD Insyte Autoguard Shielded IV Catheter 381812Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD YEL 24GA X .75IN · Class 2
All models of BD Insyte Autoguard Shielded IV Catheter (4)
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 in a blood vessel. Many of the 305 reports describe fluid leaking or splashing, the safety needle not retracting after use, and parts breaking or developing holes. The reports include 7 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
- 304
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 00382903818129), received between Oct 16, 2017 and Sep 28, 2026 — classified as 7 injuries, 297 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (86 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/Splash86
- Retraction Problem49
- Device Contamination with Chemical or Other Material44
- Material Puncture/Hole32
- Break31
- Defective Component17
- Fluid/Blood Leak10
- Material Rupture8
Patient problems
- No Clinical Signs, Symptoms or Conditions172
- No Known Impact Or Consequence To Patient68
- No Consequences Or Impact To Patient24
- Insufficient Information10
- No Patient Involvement9
- Pain6
- Discomfort5
- Skin Inflammation/ Irritation4
Recent adverse event reports
The 25 most recent of 304 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923608 ↗MalfunctionSep 24, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.It was reported that safety device did not function.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885990 ↗MalfunctionSep 24, 2026Material Perforation; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881897 ↗MalfunctionSep 22, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859145 ↗MalfunctionSep 22, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859135 ↗MalfunctionJun 17, 2026Retraction Problem
IT WAS REPORTED THAT BEFORE EMPTYING THE STERILIZER, NOTICE THAT THE SPRINGER WAS STRETCHED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537314 ↗MalfunctionApr 10, 2026Leak/Splash
THIS IS A REPORT ABOUT LEAKAGE. ACCORDING TO THE CUSTOMER¿S REPORT, THERE WAS A FLUID LEAKAGE FROM THE CATHETER HUB. DRUG LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844058 ↗MalfunctionFeb 26, 2026Contamination
IT WAS REPORTED THAT DIRT/RUST ON THE INSIDE. AFTER SPEAKING WITH OUR NURSING STAFF THEY CONFIRMED IT WAS ABOUT 10 CANNULAS THAT HAD SIMILAR PROBLEMS AND THEY ADVISED THAT SOME THAT DIDN'T HAVE ANY VISUAL ISSUES WERE ¿STICKY¿ AND THEREFOR ALSO NOT USEABLE .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24458217 ↗MalfunctionFeb 6, 2026Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283817 ↗MalfunctionJan 12, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046144 ↗MalfunctionDec 29, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
EVIDENCE OF CATHETER (PROTECTOR) PERFORATED BY THE BEVEL. OUTCOME OF THE ADVERSE EVENT OR INCIDENT: NO HARM. DETECTION OF THE ADVERSE EVENT/INCIDENT: DURING USE OF THE MD. CLASSIFICATION: NON-SERIOUS ADVERSE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23910150 ↗MalfunctionDec 16, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815738 ↗MalfunctionDec 16, 2025Material Puncture/Hole; Material Puncture/Hole
DEFECTIVE NEEDLE COLLECTION DEVICE, WHICH TORE THE JELCO AND MADE A NEW HOLE IN THE PATIENT'S LIMB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815641 ↗MalfunctionDec 16, 2025Material Puncture/Hole; Material Puncture/Hole
DURING THE PERIPHERAL PUNCTURE PROCEDURE, WHEN REMOVING THE NEEDLE, THE JELCO WAS TRANSFIXED, RESULTING IN THE LOSS OF AVP, REQUIRING A NEW PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815639 ↗MalfunctionDec 15, 2025Retraction Problem; Material Split, Cut or Torn; Retraction Problem; Material Split, Cut or Torn
COULD YOU PLEASE CONFIRM AND PROVIDE THE EXACT EVENT DATE AND AWARENESS DATE IN THE FORMAT DD-MMM-YYYY? EVENT DATE: 18-NOV-2025. AWARENESS DATE: 26-NOV-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805163 ↗MalfunctionDec 14, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE NEEDLE COULD NOT BE RETRACTED AFTER THE PUNCTURE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799472 ↗MalfunctionDec 14, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799441 ↗MalfunctionDec 4, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718945 ↗MalfunctionNov 15, 2025Material Deformation; Material Deformation
THE NEEDLE BECAME BLUNT DURING INSERTION, THE SAFETY DEVICE FELL OFF, AND THE PRODUCT COULD NOT BE RETURNED TO ITS ORIGINAL CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23564029 ↗MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478636 ↗MalfunctionNov 4, 2025Material Deformation; Material Deformation
MalfunctionNov 4, 2025Material Puncture/Hole; Material Puncture/Hole
MalfunctionOct 30, 2025Material Rupture; Material Rupture
MalfunctionOct 30, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT MANY OF THE INDIVIDUAL PACKAGING SEALS HAD PEELED OFF BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421209 ↗MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CAUSE OF THE ABNORMALITY IS UNKNOWN (NOT MARKED BY THE CUSTOMER) (B)(6) 2025. THE CUSTOMER DOESN¿T RESPOND AND THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE CUSTOMER;
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375578 ↗
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-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-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-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-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-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-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-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-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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