BD Insyte Autoguard 382544Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC GRN 18GA X 1.16IN · 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 IV catheter is a short-term catheter used for intravenous access. The 438 reports mostly describe the protective needle failing to retract or retracting slowly, and some describe blood spraying during use. There are 9 injuries, 429 malfunctions and no deaths. There is 1 open recall, started in May 2025, about the needle being slow to retract or failing to retract.
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
- 437
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 437 adverse event reports that list this exact device (DI 00382903825448), received between Nov 6, 2017 and Sep 30, 2026 — classified as 9 injuries, 428 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (285 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-2005-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem285
- Leak/Splash51
- Fluid/Blood Leak46
- Break16
- Device Contamination with Chemical or Other Material12
- Material Split, Cut or Torn9
- Backflow8
- Defective Component8
Patient problems
- No Clinical Signs, Symptoms or Conditions294
- No Known Impact Or Consequence To Patient55
- Insufficient Information54
- No Consequences Or Impact To Patient14
- Needle Stick/Puncture10
- No Patient Involvement5
- Pain5
- Foreign Body In Patient4
Recent adverse event reports
The 25 most recent of 437 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954465 ↗MalfunctionJun 22, 2026Activation Problem
IT WAS REPORTED THAT INSYTE AUTOG BC NEEDLE DID NOT COMPLETELY RETRACT. WHEN REMOVED AND RETRACTED, NEEDLE DID NOT COMPLETELY RETRACT. WAS THERE INJURY? REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25584305 ↗MalfunctionJun 5, 2026Leak/Splash; Mechanical Problem
18G IV CATHETER- FAILED BLOOD CONTROL VALVE. (B)(6) 2026 NO IMPACT TO THE PATIENT BUT THE NURSE GOT EXPOSED TO A SIGNIFICANT AMOUNT OF BLOOD WHEN THE VALVE DIDN'T WORK. YES, THERE WAS A DELAY IN TREATMENT DUE TO THE CLEAN-UP BUT THE LINE WAS ABLE TO STILL BE USED AND PATIENT TO GET THEIR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410401 ↗MalfunctionMay 12, 2026Material Integrity Problem
IT WAS REPORTED THAT THE NEEDLE CAUGHT ON THE CATHETER. "ATTEMPTED TO INITIATE IV ACCESS W8TY AH 18G BD IV CATHETER. THE IV CATHETER WAS ADVANCED HALFWAY UP THE NEEDLE WHEN THE RN CLICKED THE BUTTON TO ACTIVATE THE RETRACT MECHANISM. AS THE NEEDLE RETRACTED, IT GRABBED THE CATHETER AND PULLED IT OUT OF THE PATIENTS ARM."
Patient problems: Insufficient Information
MAUDE report 25150357 ↗MalfunctionMay 12, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. "AFTER DEPRESSING THE WHITE SAFETY BUTTON ON THE IV START NEEDLE IN ORDER FOR THE NEEDLE TO RETRACT, THE NEEDLE DID NOT RETRACT. THIS COULD HAVE CAUSED HARM TO THE CAREGIVER, NURSE, IF THEY HAD NOT REALIZED OR NOTICED THAT THE NEEDLE DID NOT RETRACT AS EXPECTED. EVENT DATE: 4/13/2026". ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148836 ↗MalfunctionApr 30, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044826 ↗MalfunctionApr 29, 2026Contamination
IT WAS REPORTED THAT FOREIGN MATTER WAS ON A NEEDLE. DEBRIS ON TIP OF NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032101 ↗MalfunctionApr 29, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028062 ↗MalfunctionApr 22, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. NEEDLE DID NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957615 ↗MalfunctionApr 21, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942350 ↗InjuryApr 9, 2026Retraction Problem; Material Separation
CUSTOMER STATED: PT WAS LYING IN BED; NURSES WERE PERFORMING AN EKG. ATTEMPTED TO PUT A PERIPHERAL INTRAVENOUS CATHETER TO RIGHT ARM. DURING INSERTION THERE WAS AN IMMEDIATE BLOOD FLASH AND THE PIV CATHETER ADVANCED WELL, THE BUTTON ON THE 18G LOT NUMBER 4162541 DID NOT RETRACT WHEN PUSHED AND HAD TO PULL TO REMOVE THE NEEDLE. THE PIV HAD BLOOD RETURN, BUT WHEN IT FLUSHED THE PIV INFILTRATED. UPON REMOVAL OF THE PIV CATHETER, IT WAS DIFFICULT TO REMOVE. SO, WE PULLED OUT THE PIV WITH SOME FORCE AND PLACED 2 X 2 WITH COBAN WRAP TO COMPRESS THE SITE. UPON INSPECTION OF THE PIV CATHETER, IT WAS NOTICEABLE THAT THE CATHETER WAS BROKEN AT THE TIP AND WAS COMPARED TO AN OPENED PIV TO VERIFY. ALSO INFORMED DR. HE ORDERED AN XRAY AND VERIFIED THERE IS A PIECE OF THE CATHETER IN PTS ARM. ADDITIONAL INFORMATION 3/23/2026: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2026 AND PATIENT RETUNED TO THE FACILITY ON (B)(6) 2026. WHAT WAS THE IMPACT TO THE PATIENT? PIECE OF TIP OF CATHETER REMAINS IN SOFT TISSUE SPAC. ADDITIONAL INFORMATION 4/6/2026: HOW WAS THE IV CATHETER REMOVED FROM THE PATIENT? USING STANDARD PROCEDURE OR PULLING THE IV STRAIGHT OUT OF THE PLACEMENT SITE, HOLDING PRESS
Patient problems: Foreign Body In Patient
MAUDE report 24830214 ↗MalfunctionApr 1, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. 18G IV NEEDLE SAFETY MALFUNCTIONED. NEEDLE SAFETY WOULD NOT ENGAGE DESPITE PRESSING THE SAFETY BUTTON MULTIPLE TIMES. ADDITIONAL INFORMATION RECEIVED 3/26/2026: DATE OF EVENT: 2/26/2026 NO PATIENT HARM, INJURY, OR COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756312 ↗MalfunctionApr 1, 2026Leak/Splash
IT WAS REPORTED THAT BLOOD LEAKED BEYOND THE SEPTUM. CUSTOMER STATES THAT THIS IV DID NOT HAVE A BLOOD CONTROL FEATURE WHEN INSERTING THE IV EXPOSURE TO BLOOD. ADDITIONAL INFORMATION 3/25/2026: THE ACCOUNT DID NOT HAVE AN EXACT DATE, BUT BETWEEN ON (B)(6). I ALSO DO NOT HAVE THE IV AS THEY DISPOSED OF IT PRIOR TO US ARRIVING. ADDITIONAL INFORMATION 3/30/2026: NO HARM OR INJURY, RN WAS WEARING GLOVES, NO EXPOSURE TO MUCOUS MEMBRANES OR BROKEN SKIN, NO DIAGNOSTICS OR MEDICAL TREATMENTS NECESSARY OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753022 ↗MalfunctionMar 30, 2026Leak/Splash; Retraction Problem
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24718438 ↗MalfunctionMar 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663900 ↗MalfunctionMar 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663899 ↗MalfunctionMar 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663898 ↗MalfunctionMar 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663897 ↗MalfunctionMar 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663891 ↗MalfunctionMar 23, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. EITHER THE NEEDLE DOES NOT RETRACT, OR IT IS SUPER SLOW TO RETRACT. YOU NEED 3 HANDS TO USE THESE! YOU SHOULD BE ABLE TO PUSH THE BUTTON AND THE NEEDLE RETRACTS COMPLETELY. NURSES ARE HAVING TO HOLD ONTO THE CATHETER THAT WOULD STAY IN THE PATIENT'S ARM, AND THEN MANUALLY REMOVE THE NEEDLE PORTION. DO YOU SEE HOW THE NEEDLE IS STILL INSIDE THE CATHETER AFTER I PUSHED THE RETRACTION BUTTON? YOU THEN HAVE TO HOLD ONTO THE GREEN PLASTIC CATHETER PART (TO HOLD IT IN THE PATIENT'S ARM) AND THEN MANUALLY PULL THE NEEDLE AWAY TO DISPOSE OF. SUPER DANGEROUS. DESCRIBE PATIENT /(HCP) / USER IMPACT: NEEDLESTICKS. ADDITIONAL INFORMATION 3/19/2026: HOW MANY NEEDLESTICK INJURIES WERE REPORTED FOR EACH LOT NUMBER? ZERO. HOW MANY OCCURRENCES FOR EACH LOT NUMBER TOOK PLACE? SEVERAL, DIDN'T COUNT. DID YOU EXPERIENCE NEEDLE RETRACTION FAILURE AND SLOW RETRACTION WITH THE SAME PATIENT OR WERE THEY ALL SEPARATE PATIENTS? SEPARATE PATIENTS. FOR EACH CONTAMINATED NEEDLESTICK THAT OCCURRED: N/A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663888 ↗MalfunctionMar 18, 2026Retraction Problem
NEEDLE NOT RETRACTING AND SEEMS TO GET STUCK ON THE CANNULA. 3/12. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? THIS WAS DISCOVERED BEFORE USE ON PATIENT. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630881 ↗MalfunctionMar 4, 2026Leak/Splash
ADDITIONAL INFORMATION 2/5/2026: ALL I HAVE SENT HAVE THE SAME ISSUES. IT IS TO THE POINT SOME SHOW UP ON MY DESK ONLY WITH A POST IT THAT THEY HAVE FAILED. IF THEY ENDED UP IN THE BOX, THEY ARE THE SAME. SORRY NOT ANY CLEARER. ORIGINAL COMPLAINT: IT WAS REPORTED BY CUSTOMER THAT THE BLOOD CONTROL FAILURE. AS NEEDLE IS RETRACTING IT PULLS THE CATHETER OUT. NURSES ARE HOLDING CATHETER TO KEEP IN PLACE.
Patient problems: Insufficient Information
MAUDE report 24506941 ↗InjuryFeb 25, 2026Break
IT WAS REPORTED THAT "DURING PLACEMENT OF IV CATHETER, FLASHBACK OBTAINED AND WHEN ATTEMPTING TO ADVANCE CATHETER, THE TIP BROKE OFF AND WAS LODGED INSIDE THE PT'S ARM". ADDITIONAL INFORMATION 2/19/2026: DATE OF OCCURRENCE WAS (B)(6) 2026. YES, THERE WAS RESISTANCE WHEN TRYING TO ADVANCE THE CATHETER AFTER GETTING FLASHBACK SITE WAS VERY PAINFUL/TENDER FOR PATIENT AND PIECE OF CATHETER WAS PALPABLE AT THE SITE, NO OTHER SYMPTOMS NOTED THE PROVIDER ATTEMPTED TO EXTRACT THE RETAINED TIP USING STERILE PROCEDURE WITH A SCALPEL AND STERILE INSTRUMENTS BUT WAS UNSUCCESSFUL. WE ATTEMPTED TO USE US TO LOCATE THE RETAINED TIP, BUT THIS WAS ALSO UNSUCCESSFUL. THE PROVIDER CONSULTED GENERAL SURGERY, BUT I'M NOT SURE WHAT THE FOLLOW-UP WAS WITH THAT. FROM MY UNDERSTANDING, THE FOLLOWING NIGHT THE PATIENT REPORTED THAT THE PAIN IMPROVED AND NOTHING ELSE WAS DONE, BUT I AM NOT 100% SURE. CORRECT, IT WAS THE TIP OF THE PLASTIC CATHETER. NEEDLE WAS COMPLETELY INTACT.
Patient problems: Foreign Body In Patient
MAUDE report 24448067 ↗MalfunctionFeb 19, 2026Difficult or Delayed Separation
REPORTED ISSUE: CUSTOMER CALLED IN STATING NEEDLE WAS DIFFICULT TO REMOVE FROM CATHETER DURING PATIENT USE. THIS INCIDENT WAS REPORTED TO ME ON (B)(6) 2026. THE PATIENT'S IV ACCESS WAS DELAYED AND HAD TO BE REATTEMPTED, BUT NO DIRECT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390099 ↗MalfunctionFeb 17, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370217 ↗
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-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-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-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-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-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-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 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
- BD Insyte Autoguard Shielded IV Catheter 381834Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days388 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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