Insyte Autoguard 381912Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ Winged Shielded Catheter IV 24 GA x 0.75 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard winged IV catheter is a short-term intravenous line used for infusions. Most of the 36 reports describe the needle being slow to retract or the plastic fraying and shearing during insertion, along with leaking and fluid leaking into surrounding tissue. There are 6 injuries and no deaths. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00382903819126), received between Apr 13, 2024 and Jun 8, 2026 — classified as 6 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (16 reports).
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 Problem16
- Adverse Event Without Identified Device or Use Problem6
- Break2
- Defective Component2
- Device Contamination with Chemical or Other Material2
- Fluid/Blood Leak2
- Connection Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Extravasation6
- Necrosis6
- Swelling/ Edema6
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026
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 25425925 ↗MalfunctionJun 8, 2026
PRODUCT "SHEARED" IN PATIENT'S SKIN DURING THE IV INSERTION. CATHETER WAS REMOVED FROM PATIENT FULLY INTACT.
Patient problems: Foreign Body In Patient
MAUDE report 25425878 ↗MalfunctionJun 3, 2026Retraction Problem
IT WAS REPORTED THAT THE SAFETY DEVICE DID NOT WORK DURING USE. NEEDLE STICK MECHANISM NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382735 ↗MalfunctionMay 27, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. "DESCRIBE CUSTOMER CONCERN, DETAILS OF EVENT INCLUDING HOW THE ISSUE WAS RESOLVED THE HEAD NURSE FROM THE ONCOLOGY CENTER AT NKTI EXPERIENCED A DELAY IN NEEDLE RETRACTION WHILE USING THE INSYTE AUTOGUARD G24 FOR A PATIENT UNDERGOING CHEMOTHERAPY INFUSION. INITIALLY, SHE BELIEVED THE ISSUE WAS ISOLATED TO A SINGLE DEVICE. HOWEVER, UPON REPEATED USE OF DEVICES FROM THE SAME BATCH AND LOT NUMBER, SHE CONSISTENTLY OBSERVED THE SAME DELAY. AFTER INSERTION, THE NEEDLE TOOK A FEW SECONDS TO FULLY RETRACT, UNLIKE OTHER BATCHES WHERE THE NEEDLE RETRACTS IMMEDIATELY. DESCRIBE IMPACT TO PATIENT, HCP, USER OR OTHER, INCLUDING RECOVERY, IF APPLICABLE? UPON CHECKING 3¿5 PIECES FROM THE SAME BATCH AND LOT NUMBER, THE SUPERVISOR DECIDED TO ESCALATE AND FORMALLY REPORT THE INCIDENT. ACCORDING TO THE END USERS, THE DELAYED NEEDLE RETRACTION CAUSED STRESS FOR BOTH NURSES AND PATIENTS. THEY ALSO EXPRESSED CONCERN REGARDING THE AFFECTED BATCH AND REQUESTED ITS REPLACEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301839 ↗MalfunctionMay 20, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. "DESCRIBE CUSTOMER CONCERN, DETAILS OF EVENT INCLUDING HOW THE ISSUE WAS RESOLVED THE HEAD NURSE FROM THE ONCOLOGY CENTER AT (B)(6) EXPERIENCED A DELAY IN NEEDLE RETRACTION WHILE USING THE INSYTE AUTOGUARD G24 FOR A PATIENT UNDERGOING CHEMOTHERAPY INFUSION. INITIALLY, SHE BELIEVED THE ISSUE WAS ISOLATED TO A SINGLE DEVICE. HOWEVER, UPON REPEATED USE OF DEVICES FROM THE SAME BATCH AND LOT NUMBER, SHE CONSISTENTLY OBSERVED THE SAME DELAY. AFTER INSERTION, THE NEEDLE TOOK A FEW SECONDS TO FULLY RETRACT, UNLIKE OTHER BATCHES WHERE THE NEEDLE RETRACTS IMMEDIATELY. DESCRIBE IMPACT TO PATIENT, HCP, USER OR OTHER, INCLUDING RECOVERY, IF APPLICABLE? UPON CHECKING 3¿5 PIECES FROM THE SAME BATCH AND LOT NUMBER, THE SUPERVISOR DECIDED TO ESCALATE AND FORMALLY REPORT THE INCIDENT. ACCORDING TO THE END USERS, THE DELAYED NEEDLE RETRACTION CAUSED STRESS FOR BOTH NURSES AND PATIENTS. THEY ALSO EXPRESSED CONCERN REGARDING THE AFFECTED BATCH AND REQUESTED ITS REPLACEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233900 ↗MalfunctionMay 15, 2026Material Frayed; Leak/Splash
IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED LEAKED. THE NURSE ATTEMPTED A PERIPHERALLY INSERTED IV PLACEMENT IN THE PATIENT'S LEFT HAND. THE IV SITE WAS LEAKING, WITH THE NEEDLE STILL IN THE CATHETER. AS THE NURSE PULLED THE IV OUT, IT WAS THAT THE TIP OF THE CATHETER WAS FRAYED. NO INFILTRATION OR EXTRAVASATION WAS NOTED. ADDITIONAL INFORMATION 5/7/2026: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE OR SERIOUS INJURY TO THE PATIENT. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25188544 ↗MalfunctionApr 29, 2026
THE NURSE ATTEMPTED A PERIPHERALLY INSERTED IV PLACEMENT IN THE PATIENT'S LEFT HAND. THE IV SITE WAS LEAKING, WITH THE NEEDLE STILL IN THE CATHETER. AS THE NURSE PULLED THE IV OUT, IT WAS THAT THE TIP OF THE CATHETER WAS FRAYED. NO INFILTRATION OR EXTRAVASATION WAS NOTED. THE IV WAS PLACED IN A BIOHAZARD BAG TO BE SENT TO SUPPLY CHAIN QA [QUALITY ASSURANCE] NURSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028071 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866363 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866362 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866345 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866341 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866337 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Extravasation; Necrosis; Swelling/ Edema
MAUDE report 24866335 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689002 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688976 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688974 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688956 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688954 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688573 ↗MalfunctionMar 25, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688565 ↗MalfunctionMar 2, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. INSYTE AUTOGUARD INSIDE THE IV INSERTION KIT ISSUED IN HAS BEEN REPORTED HAVING A DEFECT WHILE THEY PUSH THE BUTTON FOR NEEDLE ENCAPSULATION OF THE CATHETER. THEY HAVE MENTIONED THAT THEY HAVE A HARD TIME USING IT AS IT DELAYS NEEDLE ENCAPSULATION WHICH MAKES THE BUTTON HARDER TO PRESS DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482428 ↗MalfunctionFeb 26, 2026Material Protrusion/Extrusion
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462016 ↗MalfunctionFeb 18, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380828 ↗MalfunctionOct 31, 2025Retraction Problem; Retraction Problem
DATE OF OCCURRENCE: ON (B)(6) 2025. THE PRODUCT EASILY PROTRUDES DURING PERIPHERAL VENOUS PUNCTURE; TOUCHING THE DEVICE ACTIVATES IT, CAUSING THE NEEDLE TO PROTRUDE AND RESULTING IN LOSS OF VENOUS ACCESS. WAS THE CAUSE OF THE OCCURRENCE DETECTED? IF SO, DESCRIBE THE CAUSE. PRODUCT EASILY PROTRUDE DURING PERIPHERAL VENOUS PUNCTURE. AFTER THE CAUSE OF THE OCCURRENCE WAS DETECTED, WERE MEASURES TAKEN? IF SO, DESCRIBE THE MEASURES. YES. ALWAYS PERFORM VENOUS PUNCTURE WITH TWO TECHNICIANS TO ASSIST IN MOBILIZING THE LIMB TO BE PUNCTURED, TO AVOID OR MINIMIZE CATHETER PROTRUSION DURING PERIPHERAL VENOUS PUNCTURE. DID THIS OCCURRENCE CAUSE OR COULD IT CAUSE HEALTH PROBLEMS? IF YES, LOSS OF VENOUS ACCESS, FAMILY DISSATISFACTION, PATIENT EXPOSED TO A NEW PROCEDURE. DID THE EVENT LEAD TO HOSPITALIZATION? IF YES, PLACE OF HOSPITALIZATION: NA. CASE EVOLUTION: TEMPORARY INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441566 ↗MalfunctionAug 28, 2025Retraction Problem; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD INSIDE THE IV INSERTION KIT ISSUED IN AHMC HAS BEEN REPORTED HAVING A DEFECT WHILE THEY PUSH THE BUTTON FOR NEEDLE ENCAPSULATION OF THE CATHETER. THEY HAVE MENTIONED THAT THEY HAVE A HARD TIME USING IT AS IT DELAYS NEEDLE ENCAPSULATION WHICH MAKES THE BUTTON HARDER TO PRESS DURING INSERTION. NO HARM/SERIOUS INJURY TO PATIENT/HCP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912001 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page