BD Insyte Autoguard 382634Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00382903826346), received between May 3, 2018 and Jun 16, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (18 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

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  THE CUSTOMER STATED THAT ONE OF THE IAGBC CATHETERS BROKE OFF IN A PATIENT. ON (B)(6) 2026: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, THERE WAS NOT AN ADVERSE EVENT OR SERIOUS INJURY. THE EVENT WAS MISREPORTED BY SUPPLY; THE CATHETER BROKE BEFORE BEING INSERTED IN PATIENT. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 5/25/2026. ADDITIONAL REQUEST: CATHETER BROKE OFF IN THE PATIENT IS REPORTED. WAS THIS VERIFIED BY DIAGNOSTICS? WAS NOT VERIFIED BY DIAGNOSTICS; THIS WAS A MISCOMMUNICATION AND CATHETER DID NOT BREAK OFF IN PATIENT, BUT AHEAD OF TIME AS THE CLINICIAN WAS APPLYING DOWNWARD PRESSURE ON THE IV WHICH WAS BENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524205 ↗
• MalfunctionMar 2, 2026Contamination; Contamination /Decontamination Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490037 ↗
• MalfunctionSep 16, 2025Break; Break

  AFTER NEEDLE WAS REMOVED SHE WAS UNABLE TO ATTACH/THREAD EXTENSION SET TO HUB OF CATHETER DUE TO THE HUB BEING PARTIALLY BROKEN. BROKEN IV WAS THEN REMOVED AND DRESSING APPLIED. PT THEN NEEDED TO BE POKED 2 MORE TIMES TO RESTART IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066938 ↗
• MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLUGGISH WHEN RETRACTING DURING SAFETY ALLOWING BLOOD TO LEAK FROM HUB.

  Patient problems: Exposure to Body Fluids; Insufficient Information

  MAUDE report 22047468 ↗
• MalfunctionApr 22, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20G IV INSERTED WITH BLOOD FLASH INTO CHAMBER. NEEDLE WOULD NOT RETRACT BACK INTO CHAMBER FOR REMOVAL. IV HAD TO BE PULLED OUT AND ANOTHER IV PLACED IN ANOTHER LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887073 ↗
• MalfunctionApr 2, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756070 ↗
• MalfunctionApr 2, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753387 ↗
• MalfunctionMar 5, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD - INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WOULD NOT RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526256 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434324 ↗
• MalfunctionFeb 19, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED A NEEDLE STICK INJURY BECAUSE THE NEEDLE DID NOT RETRACT WHEN THE BUTTON WAS PRESSED AFTER IV INSERTION. THE PORT NEEDED TO BE OCCLUDED MANUALLY WITH PRESSURE BECAUSE IT DID NOT SELF-OCCLUDE AFTER THE NEEDLE WAS RETRACTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21416894 ↗
• MalfunctionFeb 18, 2025Retraction Problem; Defective Component; Retraction Problem; Defective Component

  CUSTOMER RESPONSE ON (B)(6) 2025. IT WAS MENTIONED THAT A 'NEEDLESTICK OCCURRED'. COULD YOU PLEASE CONFIRM WHETHER IT WAS A CLEAN NEEDLESTICK OR A CONTAMINATED ONE? CONTAMINATED. CUSTOMER RESPONSE ON (B)(6) 2025. YES, THERE WAS A NEEDLE STICK INJURY DUE TO THE NEEDLE NOT RETRACTING ALONG WITH ADDITIONAL BLOOD EXPOSURE BECAUSE THE CATHETER DID NOT AUTOOCCLUDE. CUSTOMER RESPONSE ON (B)(6) 2025. WE FOLLOWED OUR BLOOD BORNE EXPOSURE POLICY. OUR EMPLOYEE CHECKED INTO THE ED FOR EVALUATION AND LAB TESTS. THE PATIENT WAS ALSO TESTED. NOTHING CAME BACK POSITIVE AS FAR AS I AM AWARE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21401298 ↗
• MalfunctionJan 2, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 GAUGE NEEDLES - NURSES HAVE NOTICED DIFFICULTY IN THE NEEDLES NOT RETRACTING BACK IN ONCE THEY HAVE BEEN USED. WHEN THEY PUSH THE BUTTON TO RETRACK THE NEEDLE, THE NEEDLE GETS STUCK AND THEY HAVE TO USE THEIR FINGER TO ASSIST IT TO RETRACT. EVEN THOUGH THEY PUSH THE BUTTON MULTIPLE TIMES IT DOES NOT RETRACT. HOWEVER WHEN THEY TESTED A NEEDLE THAT HAS NOT BEEN USED ON A PATIENT, THE NEEDLE RETRACTS AS DESIGNED. THIS ISSUE MAY BE RELATED TO THE LOT, BUT IT ONLY OCCURS WHEN USED ON A PATIENT. THEY HAVE SAID THEY DO NOT HAVE ISSUES ON THE 22 GAUGE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060531 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  MATERIAL: 382634. BATCH#: 4172507. IT WAS REPORTED BY THE CUSTOMER THAT WHEN ADVANCED, THE CATHETER SECTION SPLIT APART FROM THE NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912999 ↗
• MalfunctionDec 11, 2024Defective Component; Defective Component

  MATERIAL#: 382634, BATCH#: 4260456. IT WAS REPORTED BY CUSTOMER THAT WE HAVE FOUND A DEFECT IN 3 20 GAUGE IV CATHETERS. THE PART OF THE CATHETER THAT CONNECTS TO THE HEPLOCK IS WARPED. BECAUSE OF THIS IT WON'T CONNECT. THE IV HAS TO BE REMOVED AND THE PATIENT HAS TO BE STUCK AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903666 ↗
• MalfunctionNov 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING HOLE NOTED IN CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HERE IT IS. THE CRACKED CATHETER WASN¿T SAVED. LET ME KNOW IF YOU NEED ANY OTHER INFORMATION. 20 GUAGE PLACED BY THIS RN. NEEDLE RETRACTED. PRIOR TO ADVANCING THE CATHETER THE REST OF THE WAY A HOLE WAS NOTED IN THE PLASTIC SHEATH BECAUSE BLOOD WAS DRIPPING FROM THE HOLE. IV WAS DCD PRIOR TO ADVANCING. 6 NOV: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678896 ↗
• MalfunctionJul 10, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WOULD NOT RETRACT AND THE BUTTON WAS STUCK. SO FAR ONLY ONE AFFECTED NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715775 ↗
• MalfunctionJul 8, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696598 ↗
• MalfunctionMar 19, 2024Retraction Problem; Retraction Problem

  ADDITIONAL INFORMATION: NO PROBLEMS WITH THE NEEDLE RETRACTION SPRING. ONCE THE COLORED PART IS OFF THE HUB, THE NEEDLE COMES IN CONTACT WITH COLORED HUB CREATING RESISTANCE WHEN THREADING. THERE HAS BEEN NO VISIBLE DAMAGE SEEN. BLOOD EXPOSURES TO ANY SURFACES HAVE NOT BEEN REPORTED, OTHER THAN THE BED, FLOOR AND PATIENT. NO REPORTS OF SERIOUS INJURIES OR HARM. NO MEDICAL OR SURGICAL INTERVENTIONS WERE NEEDED FOR ANY EVENTS. REPORTED FROM MULTIPLE RNS, MANY DIFFERENT PATIENTS, AND LOT NUMBERS WERE NOT NOTED. IT SEEMS IT IS MAINLY THE NON-BLOOD CONTROL NEEDLES. THE MAIN PROBLEM SEEN IS RESISTANCE WHEN THREADING DUE TO NEEDLE TOUCHING THE PLASTIC COLORED PART OF THE CANNULA ONCE IT IS UNSEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934829 ↗
• MalfunctionFeb 5, 2024Crack; Crack

  ADDITIONAL INFORMATION: 1) WAS THERE A BREAK IN THE METAL NEEDLE CANNULA? NO. 2) WAS THERE A BREAK IN THE IV CATHETER (HOSE)? NO. 3) WAS THERE A CRACK IN THE LUER CONNECTOR OF THE IV CATHETER? THE CRACK IS IN THE NECK OF THE IV CATHETER JUST BEFORE IT NARROWS DOWN TO THE "HOSE". 4) DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES, IT WAS INSIDE THE PT AND THE NURSE HAD REMOVED THE NEEDLE, ATTACHED A PIGTAIL AND BLOOD KEPT RUNNING OUT SO SHE DISCOVERED THE CRACK. 5) PLEASE CONFIRM THE NUMBER OF OCCURRENCES. THIS SPECIFIC INCIDENT HAS OCCURRED ONCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18642006 ↗
• MalfunctionNov 19, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER IS FRAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATH WOULD NOT DEPLOY. ADD INFO RECEIVED 1ST CUSTOMER RESPONSE ARE YOU ABLE TO PROVIDE ADDITIONAL INFORMATION OF THE REPORTED ISSUE? N.A WHAT IS MEANT BY ¿CATHETER WOULD NOT DEPLOY¿? MY IV NURSE WAS ABLE TO GET INTO THE VEIN, BUT WHEN SHE TRIED TO THREAD THE CATHETER OFF THE NEEDLE IT WOULD NOT ADVANCE INTO THE VEIN. SHE SAID THAT IT WAS LIKE IT WAS FRAYED. DID THE NEEDLE FAIL TO RETRACT? SHE DID NOT ATTEMPT TO DEPLOY THE NEEDLE. THE CATH DID NOT THREAD OFF. DID THE CATHETER APPEAR ADHERED TO THE NEEDLE OR NEEDLE COVER? SHE WAS NOT SURE. . . . WHAT DOES THE CATH TIP LOOK LIKE, IS IT FRAYED? WERE THEY ABLE TO PIERCE THE SKIN BUT NOT THREAD THE CATHETER? - AS YOU CAN SEE THERE WAS BLOOD IN THE CHAMBER, THEREFORE, SHE WAS IN THE VEIN. SHE SAID IT WAS A GOOD STICK, BUT A DEFECTIVE NEEDLE/CATH WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? - THEY HAD TO BE STUCK AGAIN, BUT NO DAMAGE TO THE PT. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? - PT REQUIRED 2 STICKS VERSUS 1 STICK WHAT TYPE OF PROCEDURE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167188 ↗
• MalfunctionOct 2, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER'S NEEDLE WOULD NOT RETRACT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: INSYTE IV MALFUNCTIONED. BUTTON TO RETRACT NEEDLE WAS ACTIVATED AND WAS STUCK DOWN WITHOUT NEEDLE RETRACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858118 ↗
• MalfunctionNov 18, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE DID NOT FULLY RETRACT AFTER THE BUTTON WAS PRESSED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN PLACED 20G HEPLOCK IN RIGHT ANTERIOR CHAMBER. RN PUSHES WHITE BUTTON TO RELEASE NEEDLE AND RETRACTION ONLY OCCURRED PARTIALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822144 ↗
• MalfunctionNov 17, 2022Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER DURING USE AND FAILED TO RETRACT AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN PLACED 20G HEPLOCK IN RIGHT ANTERIOR CHAMBER. RN PUSHES WHITE BUTTON TO RELEASE NEEDLE AND RETRACTION ONLY OCCURRED PARTIALLY. IV PULLED AND IV WAS FOUND TO HAVE THE NEEDLE SHEARED THROUGH THE PLASTIC CATHETER. PATIENT DID NOT RECEIVE INJURY. SLIGHT BRUISING NOTED AT SITE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815759 ↗
• MalfunctionMay 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD THE CATHETER SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE IV CATHETER DISCONNECTS.   VERBATIM: THE IV CATH. DISCONNECTS AT THE HUB THEY ARE BOTH 20G AND 22G IV CATHETERS.

  Patient problems: Insufficient Information

  MAUDE report 14317921 ↗
• MalfunctionMay 7, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER THE NEEDLE DOES NOT RETRACT THE IV CATH. THE NEEDLE DOES NOT RETRACT. THEY ARE BOTH 20G AND 22G IV CATHETERS.

  Patient problems: Insufficient Information

  MAUDE report 14317400 ↗

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-2000-2025 · May 21, 2025 · Open, Classified
  REF: 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-2003-2025 · May 21, 2025 · Open, Classified
  REF: 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-2006-2025 · May 21, 2025 · Open, Classified
  REF: 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-2007-2025 · May 21, 2025 · Open, Classified
  REF: 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, Classified
  REF: 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, Classified
  REF: 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, Classified
  REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
• Z-2002-2025 · May 21, 2025 · Open, Classified
  REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
• Z-2001-2025 · May 21, 2025 · Open, Classified
  REF: 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, Classified
  BD 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, Classified
  BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533