BD Insyte Autoguard 381447Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD GN 18GA X 1.88IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903814473), received between Mar 7, 2018 and Jul 28, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (4 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 Problem4
- Defective Component1
- Defective Device1
- Disconnection1
- Material Puncture/Hole1
- Material Separation1
- Material Twisted/Bent1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Retraction Problem; Retraction Problem
MalfunctionJul 28, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD INSTANCES WHERE DEVICE DID NOT RETRACT PROPERLY. ONE INCIDENT RESULTED IN A COLLEAGUE STICK.
Patient problems: Insufficient Information
MAUDE report 22637728 ↗MalfunctionJul 22, 2024Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801617 ↗MalfunctionMar 27, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18988004 ↗MalfunctionOct 3, 2023Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17866120 ↗MalfunctionMar 1, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 18G X 1.88" THE NEEDLE DOES NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN YOU PRESS THE BUTTON TO RETRACT THE NEEDLE, IT ONLY RETRACTS PART WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464011 ↗MalfunctionMar 24, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT WHILE USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, THE CATHETER KINKED AND BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE CRIMPING WHILE TRYING TO START THE IV AND REMAIN CRIMPED WHEN REMOVING THE NEEDLE.
Patient problems: Perforation of Vessels
MAUDE report 13892696 ↗MalfunctionFeb 18, 2019Retraction Problem
IT WAS REPORTED WITH THE USE OF THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER THERE WAS AN ISSUE WITH THE CATHETER FAILING TO FULLY RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8348674 ↗MalfunctionOct 11, 2018Use of Device Problem; Defective Device
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD NEEDLE DEFECTS THAT CAUSED DIFFICULTY IN USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7956220 ↗MalfunctionAug 9, 2018Unsealed Device Packaging
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE RECEIVED WITH BROKEN PACKAGING SEALS RESULTING IN A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7770235 ↗MalfunctionMar 7, 2018Disconnection
IT WAS REPORTED DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ¿THE CATHETER DISCONNECTED FROM THE CATHETER HUB.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7322651 ↗
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-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-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-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-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-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-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-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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