BD Insyte Autoguard 381467Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD ORN 14GA X 1.75IN · 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 shielded IV catheter is a short-term intravascular catheter used for IV access. The 48 reports mostly describe the needle failing to retract after use, so the safety mechanism never activates. Others mention packaging that will not open, sterilization concerns, and one report of the catheter separating from its hub and staying in the patient's arm. There are 2 injuries and no deaths, and most reports say the patient was not affected. 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
- 48
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00382903814671), received between Nov 30, 2017 and Nov 21, 2022 — classified as 2 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (9 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.
Most reported problems
Device problems
- Retraction Problem9
- Packaging Problem7
- Device Disinfection Or Sterilization Issue6
- Physical Resistance5
- Problem with Sterilization5
- Break3
- Degraded3
- Tear, Rip or Hole in Device Packaging3
Patient problems
- No Known Impact Or Consequence To Patient40
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED BY THE CUSTOMER THAT 15 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WILL NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER BELIEVES THEY RECEIVED A BAD LOT AS THEY HAD 15EA SO FAR FROM THIS ORDER WHERE THE SPRING IN THEM WILL NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840691 ↗MalfunctionJun 1, 2020Retraction Problem
IT WAS REPORTED THAT 15 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS FROM LOT# 9119988, 1 CATHETER FROM LOT# 8212900, 1 CATHETER FROM LOT# 9031615, 29 CATHETERS FROM LOT# 8318966, AND 61 CATHETERS FROM LOT# 9225178 WOULD NOT RETRACT THEIR NEEDLE WHEN THEIR BUTTON WAS PRESSED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT IS BD INSYTE AUTOGUARD 14GA IV NEEDLE. SOME OF OUR STAFF NOTICED THAT WHEN THE RETRACT BUTTON IS PUSHED THE NEEDLE DOES NOT RETRACT. IT STICKS INSIDE THE CATHETER CREATING A SAFETY ISSUE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10107348 ↗MalfunctionFeb 24, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE PACKAGING FOR THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 14GA 1.75IN DID NOT OPEN PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: MATERIAL NO: 381467 BATCH NO: 9119988. IT WAS REPORTED THAT AT LEAST FOUR PACKAGES RIPPED WHILE CORRECTLY OPENING THEM. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I RECEIVED ANOTHER PACKAGE WRAPPER FROM THE OR TODAY FOR 381467 (INSYSTE). THEY HAVE OPENED AS MANY AS 4 TRYING TO GET ONE TO OPEN CORRECTLY. WHEN THE PAPER RIPS IT'S CONSIDERED A NON-STERILE OPENING BECAUSE PAPER DUST IS CREATED. LOT # 9119988.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9745809 ↗MalfunctionNov 21, 2019Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF CANNULATED PATIENT AND THE DEVICE FAILED TO RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9356485 ↗MalfunctionNov 21, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE 14G X 1.75IN (2.1 X 45 MM) INSYTE AUTOGUARD EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE CANNULATED PATIENT AND ATTEMPTED TO DEPLOY SAFETY ON CANNULA BY DEPRESSING THE BUTTON. NEEDLE DID NOT RETRACT AND HUB STAYED ATTACHED TO CANNULA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9355342 ↗InjuryOct 23, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381467 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE CATHETER SEPARATED FROM THE HUB OF THE IV AND REMAINED IN THE PATIENT'S ARM. GOOD MORNING, THERE WAS AN EVENT REPORTED ON RHOADS 4 THAT NEEDS F/U. WE DO NOT HAVE THE CATHETER. I HAVE COPIED CLINICAL LEADERSHIP ON THIS EMAIL IN ORDER TO EXPEDITE THE INFORMATION GATHERING PROCESS. PLEASE KEEP IN MIND WE DO NOT SHARE PATIENT INFORMATION. PATIENT HAD A LEFT AC 14G IV. IV NO LONGER INDICATED. UPON REMOVING IV, CATHETER SEPARATED FROM HUB OF IV AND REMAINED IN PATIENTS VEIN. TRANSPLANT MD CAME TO BEDSIDE AND WAS ABLE TO RETRIEVE CATHETER. PATIENT REQUIRED SMALL INCISION TO REMOVE CATHETER THAT WAS THEN COVERED WITH A STERISTRIP.
Patient problems: No Code Available
MAUDE report 9227042 ↗MalfunctionJul 17, 2019Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT BD MICRO-FINE ULTRA¿ PEN NEEDLES ARE CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT NEEDLES ARE CLOGGED. PATIENT INDICATED THAT PART OF THE INSULIN DID NOT COME OUT OF THE NEEDLE AT FIRST, BUT THAT AFTER HOLDING IT, SUDDENLY A LOT CAME OUT AT ONCE. RESULT: SORE LEG. SOMETIMES NO INSULIN CAME OUT OF THE PEN AT ALL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8800222 ↗MalfunctionJun 10, 2019Misconnection; Misconnection
IT WAS REPORTED THAT BD MICRO-FINE ULTRA¿ PEN NEEDLE WAS CLOGGED. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT CAME ALONG WHO HAS TYPE 2 DIABETES AND REGULARLY USES BD MICROFINE NEEDLES 4MM. SHE ALREADY HAD SEVERAL NEEDLES, NAMELY 10, OF THE BOX WITH LOT 8269503 OF MICROFINE ULTRA4MM 100 WHICH NEEDED TP BE THROWN AWAY AS THEY WERE CLOGGED. INFORMATION RECEIVED ON 06/05: USER DIDN'T HAVE ANY CONSEQUENCES, NEEDLES WERE CLOGGED AND SHE HAD TO USE THE NEW ONE. SHE HAS BEEN DIABETIC FOR YEARS AND HAS BEEN USING BD MICROFINE 4MM. THIS WAS THE FIRST TIME, WHEN SHE ENCOUNTERED THIS PROBLEM, FORTUNATELY WITH NO CONSEQUENCES. SHE THREW THE NEEDLES AWAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8684266 ↗MalfunctionFeb 19, 2019Retraction Problem
IT WAS REPORTED THAT 3 OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' HAD NEEDLES THAT WOULDN'T RETRACT AND THEIR HUBS WOULDN'T THREAD DURING USE. LOT #: 8212900 WAS REPORTED TO HAVE HAD 2 OCCURRENCES OF THIS EVENT AND LOT#: 8127892 WAS REPORTED TO HAVE HAD 1 OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8351493 ↗MalfunctionDec 31, 2018Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT DURING USE OF THE BD MICRO-FINE ULTRA¿ PEN NEEDLE THE NEEDLES WERE CLOGGED. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206996 ↗MalfunctionDec 14, 2018Problem with Sterilization
IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD HAD STERILITY BREACH BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8165664 ↗MalfunctionNov 9, 2018Packaging Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PACKAGING CAME APART. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8056419 ↗MalfunctionNov 9, 2018Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PACKAGING CAME APART. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8056416 ↗MalfunctionOct 9, 2018Break
IT WAS REPORTED THAT A BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD A BROKEN SEAL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7947859 ↗MalfunctionOct 5, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD ADHESIVE FAILURE WHICH CAUSED A BREACH IN STERILITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7939915 ↗MalfunctionOct 4, 2018Packaging Problem
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FAILURE WITH THE PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7935775 ↗MalfunctionOct 2, 2018Break; Packaging Problem
IT WAS REPORTED THAT THE PACKAGING FOR A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A BROKEN SEAL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7926893 ↗MalfunctionOct 2, 2018Loss of or Failure to Bond
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD PACKAGING ADHESIVE FAILURE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7926891 ↗MalfunctionOct 2, 2018Delivered as Unsterile Product
IT WAS REPORTED THAT A BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILE BREACH DUE TO THE FAILURE OF THE PACKAGING ADHESIVE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7926844 ↗MalfunctionSep 28, 2018Leak/Splash
IT WAS REPORTED THAT A BD MICRO-FINE ULTRA¿ PEN NEEDLE HAD LEAKAGE BETWEEN THE NEEDLE AND THE PLASTIC HUB. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7918996 ↗MalfunctionSep 25, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PACKAGING FOR A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD ADHESIVE THAT FAILED TO KEEP THE PACKAGING CLOSED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7906398 ↗MalfunctionSep 14, 2018Problem with Sterilization
IT WAS REPORTED BEFORE USE A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A STERILE BREACH DUE TO PACKAGING THAT WAS SLIGHTLY OPENED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7877545 ↗MalfunctionAug 21, 2018Problem with Sterilization
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A STERILE BREACH DUE TO PACKAGING THAT WAS SLIGHTLY OPENED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7802156 ↗MalfunctionJul 22, 2018Problem with Sterilization
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7709462 ↗MalfunctionJul 22, 2018Packaging Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7709460 ↗
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-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-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-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-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-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-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.
How reports and recalls are matched · Editorial policy · Report an error on this page