BD Insyte Autoguard 381433Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Insyte Autoguard is an IV catheter with a needle meant to retract into a safety shield. Most of the 313 reports describe the needle not retracting or retracting slowly, and there were 20 injury reports and no deaths. There is 1 open recall, from May 2025, over needles that may be slow to retract or fail to retract. Reports fell to 10 in the latest 12 months from 148 in the 12 months before.
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
- 314
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 314 adverse event reports that list this exact device (DI 00382903814336), received between Oct 17, 2017 and Sep 16, 2026 — classified as 20 injuries, 294 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (204 reports).
1 FDA recall record name this device's identifier, 1 still open.
10 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
- May 21, 2025Class IIOpen, Classified
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2002-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem204
- Leak/Splash43
- Device Contamination with Chemical or Other Material25
- Material Puncture/Hole22
- Break17
- Defective Component10
- Patient-Device Incompatibility8
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions189
- Insufficient Information45
- No Known Impact Or Consequence To Patient36
- No Consequences Or Impact To Patient18
- Needle Stick/Puncture9
- Vasculitis7
- Perforation of Vessels6
- Reaction4
Recent adverse event reports
The 25 most recent of 314 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787133 ↗MalfunctionApr 9, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. NEEDLE DOES NOT RETRACT FAST ENOUGH IT SLOWLY FALLS ALMOST LIKE THE SPRING INSIDE DOES NOT FUNCTION CORRECTLY ADDITIONAL INFORMATION 4/6/2026: I WAS MADE AWARE OF THIS ISSUE 3/6/2026. NO PATIENT HARM, WE TOOK THEM OFF THE SHELF AND SENT BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834690 ↗MalfunctionMar 23, 2026Retraction Problem
IT WAS REPORTED THAT NEEDLES ARE NOT RETRACTING. "NEEDLES NOT RETRACTING ON THE 20GAUGE IVS ".
Patient problems: Insufficient Information
MAUDE report 24663542 ↗MalfunctionMar 11, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574856 ↗MalfunctionDec 22, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872644 ↗MalfunctionDec 22, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872631 ↗MalfunctionDec 22, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872630 ↗MalfunctionNov 24, 2025Retraction Problem; Retraction Problem
MalfunctionNov 19, 2025Retraction Problem; Retraction Problem
ORIGIN OF THE ISSUE: NURSING. DETAIL: IV NEEDLES ARE NOT RETRACTING EFFECTIVELY AFTER USED TO START IV CUSTOMER RESPONDED ON 11-NOV. THE EVENT HAPPENED ON (B)(6) 2025. NO PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598454 ↗MalfunctionNov 18, 2025Retraction Problem; Retraction Problem
20 GAUGE IVS AGAIN NOT RETRACTING - SLOW TO RETRACT PATIENT'S SKIN WAS SHREDDED.
Patient problems: Abrasion
MAUDE report 23589205 ↗MalfunctionNov 18, 2025Retraction Problem; Retraction Problem
20 GAUGE IVS AGAIN NOT RETRACTING - SLOW TO RETRACT PATIENT'S SKIN WAS SHREDDED.
Patient problems: Abrasion
MAUDE report 23589203 ↗MalfunctionOct 28, 2025Retraction Problem; Retraction Problem
THE CUSTOMER ADVISED THAT THE PRODUCT HAS RETRACTION ISSUES WHILE IN USE ON PATIENTS.
Patient problems: Insufficient Information
MAUDE report 23409388 ↗MalfunctionOct 28, 2025Retraction Problem; Retraction Problem
THE CUSTOMER ADVISED THAT THE PRODUCT HAS RETRACTION ISSUES WHILE IN USE ON PATIENTS.
Patient problems: Insufficient Information
MAUDE report 23408542 ↗MalfunctionOct 16, 2025Dull, Blunt; Material Integrity Problem; Dull, Blunt; Material Integrity Problem
WENT TO STICK AND THE CATHETER WOULDN¿T PENETRATE SKIN. CATHETER SPLIT AT THE TIP. HAD TO STICK PATIENT AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316928 ↗MalfunctionSep 10, 2025Material Deformation; Material Deformation
INCREASED ISSUES WITH THE PLASTIC CANULA BEING MUSHROOMED AT THE END THIS MORNING, I WENT TO INSERT THE NEEDLE AND MET IMMEDIATE RESISTANCE AS THE PLASTIC CANULA MUSHROOMED AND WOULD NOT ENTER THE SKIN. 7/11/25 AT 0700 WAS WHEN IT OCCURRED AND THERE WAS NO HARM TO THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017679 ↗MalfunctionSep 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
THE PLASTIC CANULA STICKS TO THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017622 ↗MalfunctionSep 8, 2025Retraction Problem; Retraction Problem
A FEW WEEKS AGO, OUR ED/ER DEPARTMENT MANAGER NOTIFIED US THAT THE SAME PRODUCT WAS GETTING STUCK WHEN ATTEMPTING TO RETRACT THE NEEDLE WHILE IT WAS STILL INSIDE THE PATIENT'S VESSEL.
Patient problems: Insufficient Information
MAUDE report 22997179 ↗MalfunctionSep 3, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956945 ↗MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
MalfunctionSep 2, 2025Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY RETRACTION FAILURE. ADTL.CMTS: CATHETERS HAVE HOLES. CUSTOMER RESPONSE ON AUG 21, 2025. UNFORTUNATELY, I¿M UNABLE TO PROVIDE ANY FURTHER DETAILS FROM THE CUSTOMERS.
Patient problems: Insufficient Information
MAUDE report 22932373 ↗
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-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-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-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-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-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-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 · 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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