BD Insyte Autoguard 381534Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I · 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 winged IV catheter is a short-term IV placed into a vein. The 54 reports mostly describe blood leaking from the catheter, a needle that would not retract after the safety button was pressed, and catheter tips found frayed, punctured or broken. Two injuries and no deaths were reported, with 52 malfunctions. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00382903815340), received between Jan 26, 2018 and Apr 23, 2026 — classified as 2 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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/Splash21
- Retraction Problem15
- Device Contamination with Chemical or Other Material9
- Break4
- Defective Component4
- Material Puncture/Hole4
- Fluid/Blood Leak3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient20
- No Consequences Or Impact To Patient6
- Insufficient Information4
- Blood Loss1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. 20G INSYTE AUTOGUARD- IT LOOKS LIKE WE GOT A SAFETY INCIDENT EVENT WHERE THE NEEDLE WOULD NOT RETRACT WHEN THE BUTTON WAS PRESSED. ITEM WAS FROM LOT NUMBER 5309624. NEEDLE WAS NOT SAVED AND PLACED IN THE SHARPS CONTAINER.
Patient problems: Insufficient Information
MAUDE report 24968873 ↗MalfunctionMar 6, 2026Fluid/Blood Leak; Product Quality Problem
IT WAS REPORTED THAT THE CATHETER IS DAMAGED. ¿WHEN PLACING AN IV IN THIS PATIENT I NOTICED SOME BLOOD HAD LEAK AROUND THE SITE. WHEN I ADVANCED THE CATHETER AND PULLED BACK FOR LAB WORK THERE WAS NO ISSUE WITH BLOOD LEAKING AND THE IV FLUSHED WELL, NO PATIENT COMPLAINTS OF PAIN OR SYMPTOMS OF EXTRAVASATION. UPON REMOVAL OF CATHETER PLASTIC CATHETER PIECE HAD INJURY TO IT, UNABLE TO DETECT LEAK WHEN FLUSHING BUT WAS NOT SMOOTH THROUGHOUT.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535756 ↗MalfunctionMar 5, 2026Fluid/Blood Leak; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524207 ↗MalfunctionMar 5, 2026Material Puncture/Hole; Difficult to Advance
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518244 ↗MalfunctionApr 17, 2025Retraction Problem; Retraction Problem
MalfunctionFeb 13, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT ON A 24G INSYTE-N AUTOGUARD SET IT WAS REPORTED BY CUSTOMER THAT 20 GAGE IV PLACED TIP FELT BLUNT AND NO BLOOD RETURNED, PRESSED BUTTON TO RETRACT AND NEEDLE WAS STUCK RETRACTION NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381333 ↗MalfunctionMar 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTINUOUS LEAK FROM ANGIOCATH ONCE IV INSERTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18821914 ↗MalfunctionJan 26, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED HAS A DAMAGED TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER LOOKS FRAYED TOWARDS THE TIP OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18591249 ↗MalfunctionDec 7, 2023Defective Component; Defective Component
MalfunctionOct 12, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' NEEDLES CRACKED DURING THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CARDIOVASCULAR SHORT STAY DEPARTMENT SAID THAT THE NEEDLES HAVE BENT, CRACKED OR TWISTED DURING INSERTION."
Patient problems: Insufficient Information
MAUDE report 17926349 ↗MalfunctionJun 6, 2023Defective Component; Defective Component
IT WAS REPORTED THAT 18 BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED MOLDING ISSUE THAT MAKE IT DIFFICULT TO SCREW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE CUSTOMER IS STATING THAT THE MOLDING IS MAKING IT DIFFICULT TO SCREW IN THE LUER LOCK. THEY ARE BENDING WHEN YOU PLACE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073241 ↗MalfunctionFeb 11, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING THE INSTALLATION OF THE CATHETER, A NURSE FROM THE MULTIPURPOSE MEDICINE DEPARTMENT WANTED TO RETRACT THE NEEDLE BY PRESSING THE RETRACTOR BUTTON PROVIDED FOR THIS PURPOSE, BUT IT REMAINED BLOCKED, MAKING RETRACTION IMPOSSIBLE. THIS RESULTED IN A RISK OF A BLOOD EXPOSURE ACCIDENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16359710 ↗MalfunctionJan 13, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD WINGED, 20G X 1.16" FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: BLACK SPECKLES ON THE CATHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16159754 ↗MalfunctionJan 6, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD WINGED, 20G X 1.16" THE SAFETY MECHANISM FAILED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY MECHANISM IN IV CATHETER WOULD NOT RETRACT
Patient problems: Insufficient Information
MAUDE report 16118391 ↗MalfunctionDec 9, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS NOT RETRACTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSH BUTTON NOT RETRACTING THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951124 ↗MalfunctionDec 6, 2022Contamination; Contamination
IT WAS REPORTED PRIOR TO USE WITH BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I FOREIGN MATTER WAS FOUND IN 12 DEVICES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK SPECKLES IN THE PLASTIC CAP OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15925165 ↗MalfunctionDec 1, 2022Device Contamination with Chemical or Other Material
ISSUE WAS INITIALLY REPORTED BY CARDIAC CATH LAB (CCL) MANAGER WHEN DOING INVENTORY FOR SUPPLIES IN HER UNIT. SHE NOTICED BLACK DOTS/ SPECKLES IN THE PLASTIC CAP OF THE NEEDLE, NEAR THE HUB OF THE SYRINGE. SHE REPORTED IT TO MATERIALS MANAGEMENT. MANAGER OF MATERIALS MANAGEMENT THEN WENT TO LOOK FOR SYRINGES WITH THE SAME LOT NUMBER AND FOUND SEVERAL SYRINGES WITH THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892968 ↗MalfunctionOct 22, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED THE NEEDLE PIERCING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE RECEIVED A COUPLE OF THESE WITH DEFORMED CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12685714 ↗MalfunctionSep 23, 2021Retraction Problem; Retraction Problem
IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT HEALTH PROFESSIONAL PRESSED THE SAFETY BUTTON TO RETRACT NEEDLE AND THE NEEDLE WOULD NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12522974 ↗MalfunctionSep 20, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE IV CATHETER WAS PLACED WHEN THE NURSE ATTEMPTED TO FLUSH, THERE WAS LEAKING AT THE CONNECTION SITE BETWEEN THE ANGIO CATH AND EXTENSION TUBING"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12502303 ↗MalfunctionSep 9, 2021Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY PREOP NURSE MANAGER STATES THE NEEDLE IS NOT RETRACTING INTO THE SAFETY HUBS ON THE CATHETER IV INSYTE PRODUCTS, AND THIS HAPPENING FREQUENTLY WITH HER STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12444312 ↗MalfunctionAug 31, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV PLACED , WHEN I ATTEMPTED TO FLUSH LEAKING AT CONNECTION BETWEEN ANGIOCATH AND EXTENSION TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393143 ↗MalfunctionAug 3, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I WAS NOT ABLE TO CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BD INSYTE AUTOGUARD IT WILL NOT CONNECT TO THE INFUSION EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12271220 ↗MalfunctionJul 20, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WBH EMERGENCY DEPARTMENT HAS HAD SEVERAL PRODUCT FAILURE EVENTS WITH THE PRODUCT BELOW. THE ISSUE APPEARS INTERMITTENT. BD INSYTE AUTOGUARD WINGED20 GA X 1.16 IN... THERE IS A HOLE IN THE CATHETER ABOUT 1/3 OF THE WAY DOWN THE CATHETER. NO PATIENT HARM AND NO PRODUCT SAVED TO DATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12197435 ↗MalfunctionApr 20, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DEFECTIVE/DAMAGED AND WOULD NOT SCREW ONTO THE LUER LOCK OF THE EXTENSION LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "20 GAUGE IV INSERTED IN THE PATIENT AND UPON TRYING TO ATTACH THE EXTENSION LINE TO THE CATHALON IT WAS DISCOVERED THAT THERE WAS AN IMPERFECTION IN THE CATHALON THAT WOULD NOT ALLOW IT TO SCREW ON TO THE LUER LOCK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697939 ↗
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-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-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-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-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-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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