BD Insyte Autoguard 382534Recalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 00382903825349), received between Nov 13, 2017 and Sep 30, 2026 — classified as 20 injuries, 339 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (170 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 359 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954466 ↗
• MalfunctionSep 9, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698883 ↗
• MalfunctionJun 23, 2026Thickening of Material

  IT WAS REPORTED THAT CATHETER IS DAMAGED. DATE OF EVENT: 5/02/2026 OUR NURSING STAFF AT PVH HAS REPORTED THAT THIS LOT IS ROUGH/THICK, CAUSING BLOWN OUT VEINS. ALL INCIDENTS WERE NOTED IN ER, NO DELAYS OTHER THAT REATTEMPTS FOR IV ACCESS WERE NOTED. PRESSURE APPLIED TO SITE AND THIS ISSUE CAUSED PATIENTS TO HAVE MULTIPLE IV PLACEMENTS UNNECESSARILY. WAS PATIENT OR END-USER INJURED: Y WHEN WAS INCIDENT NOTICED: DURING USE WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: N.

  Patient problems: Perforation of Vessels

  MAUDE report 25598896 ↗
• MalfunctionJun 18, 2026Retraction Problem

  IT WAS REPORTED BY CUSTOMER THAT NEEDLES NOT RETRACTING. VERBATIM: NEEDLES NOT RETRACTING.

  Patient problems: Insufficient Information

  MAUDE report 25552917 ↗
• MalfunctionJun 3, 2026Retraction Problem

  REPORTED ISSUE: NEEDLE RETRACTS WITHOUT THE BUTTON BEING PUSHED AND IS CAUSING OUR NURSES TO USE MULTIPLE IV CATHETERS. THE LOT NUMBER THAT I LISTED SEEMS TO BE THE ONLY LOT THAT IS AFFECTED. HAVE YOU HEARD OF THIS ISSUE HAPPENING TO ANYONE ELSE? WE HAVE 82 AFFECTED IV CATHETERS THAT WE HAVE SEPARATED FROM OUT OTHER STOCK. IS THERE ANY WAY THAT WE CAN GET A REPLACEMENT FOR THESE DEFECTIVE ITEMS?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383653 ↗
• MalfunctionMay 21, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. (B)(6) 2026. INJURY: PATIENT VEIN BLEW.

  Patient problems: Perforation of Vessels

  MAUDE report 25244552 ↗
• MalfunctionMay 18, 2026Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER SPLIT. PLASTIC SHEATH SPLIT UPON INSERTION INTO THE SKIN WHICH MADE IT UNUSABLE. 3- 20 G IV CATHS IN A ROW MALFUNCTIONED IN A SIMILAR MANOR INVOLVING THE TIP OF THE PLASTIC PORTION OF THE CATH BREAKING. VERY SMALL PIECES OF THE BROKEN OFF END COULD HAVE ENDED UP IN THE PATIENT. THE INCIDENT WAS CAUGHT PRIOR TO IV PLACEMENT, AND A NEW LOT WAS OBTAINED. NO HARM CAME TO ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209592 ↗
• MalfunctionMay 6, 2026Insufficient Device Problem Information

  CG ACTIVATED SAFETY TO RETRACT THE IV NEEDLE. IV RETRACTED. CG STATES HE THEN ACCIDENTALLY POKED HIMSELF WITH THE PLASTIC PART WHERE THE NEEDLE GOES IN. THERE WAS BLOOD ON IT. HE CHECKED HIS GLOVE AFTER. IT WAS BROKEN AND HE HAD A SMALL LACERATION ON HIS RIGHT PALM. CG WASHED THE AREA WITH SOAP AND WATER AFTER THE INJURY. ADDITIONAL INFORMATION 4/28/2026: I'M SO SORRY FOR THE DELAY. BELOW ARE THE ANSWERS TO THE BEST OF MY KNOWLEDGE AFTER THE SWARM WITH THE CAREGIVER. DID THE NEEDLE FULLY RETRACT AS INTENDED AT THE TIME OF ACTIVATION? IT DID NOT RETRACT ALL THE WAY. WAS THERE ANY VISIBLE IRREGULARITY, SHARP EDGE, OR DEFORMATION NOTED ON THE NEEDLE RETRACTION HOUSING? NOT NOTED. WAS THE INJURY CAUSED BY THE NEEDLE ITSELF, OR BY THE NEEDLE RETRACTION HOUSING/PLASTIC COMPONENT? THE NEEDLE. WHAT TYPE OF DIAGNOSTIC OR MEDICAL EVALUATION/TREATMENT DID THE CAREGIVER RECEIVE FOLLOWING THE INJURY? BLOOD DRAW FOR CAREGIVER AND PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25093773 ↗
• MalfunctionApr 21, 2026Difficult to Advance; Material Twisted/Bent

  THIS MDR IS THE RESULT OF AN INVESTIGATION FINDING. ORIGINAL COMPLAINT WAS NOT MDR REPORTABLE FOR KINK/BEND AND DIFFICULT TO THREAD: BENT NEEDLE/CATHETER UPON OPENING PACKAGE. UNUSABLE FOR FEAR OF PATIENT HARM. RN TRIED TO USE THE NEEDLE THE FIRST TIME WITHOUT REALIZING IT WAS AFFECTED, BUT WAS UNABLE TO THREAD THE CATHETER. SHE REMOVED THE WHOLE THING AND REALIZED THERE WAS A KINK/BEND. SHE OPENED ANOTHER NEW IV AND SAW THE SAME THING BEFORE INSERTING SO DID NOT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943469 ↗
• MalfunctionApr 9, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER TIP WAS FRAYED. ON (B)(6), 2026 LABOR AND DELIVERY STAFF EXPRESSED CONCERNS ABOUT MULTIPLE MISSED STICKS USING 20 GAUGE ANGIOS. AFTER CLOSER INSPECTION OF ANGIOS THE TIP OF THE CATH IS ROUGH (NOT SMOOTHE) AND FRAYED. ADDITIONAL INFORMATION APR 2, 2026: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. MULTIPLE NURSES REPORTED HAVING TROUBLE STARTING IVS. C/O BLOWING VEINS AND REQUIRING VASCULAR ACCESS TEAM TO START. AFTER INSPECTION OF A FEW ANGIO CATHS, THESE 2 LOTS WERE FOUND TO BE ROUGH ON THE END INSTEAD OF THE USUAL SMOOTH APPEARANCE.

  Patient problems: Perforation of Vessels

  MAUDE report 24834746 ↗
• MalfunctionApr 9, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER TIP WAS FRAYED. ON (B)(6) 2026, LABOR AND DELIVERY STAFF EXPRESSED CONCERNS ABOUT MULTIPLE MISSED STICKS USING 20 GAUGE ANGIOS. AFTER CLOSER INSPECTION OF ANGIOS THE TIP OF THE CATH IS ROUGH (NOT SMOOTH) AND FRAYED. ADDITIONAL INFORMATION APR 2, 2026: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. MULTIPLE NURSES REPORTED HAVING TROUBLE STARTING IVS. C/O BLOWING VEINS AND REQUIRING VASCULAR ACCESS TEAM TO START. AFTER INSPECTION OF A FEW ANGIO CATHS, THESE 2 LOTS WERE FOUND TO BE ROUGH ON THE END INSTEAD OF THE USUAL SMOOTH APPEARANCE.

  Patient problems: Perforation of Vessels

  MAUDE report 24834692 ↗
• InjuryMar 13, 2026Leak/Splash; Material Integrity Problem

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24592312 ↗
• MalfunctionFeb 17, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369392 ↗
• MalfunctionJan 26, 2026Leak/Splash; Retraction Problem

  I RECEIVED ANOTHER SAFE REPORT YESTERDAY WITH THE SAME ISSUE BUT DIFFERENT INSYTE NEEDLE. PLEASE PROVIDE AN EXACT DATE OF EVENT: 01-12-2026. ¿UPON INSERTING PIV CATHETER INTO PATIENT, ONCE FLASH WAS SEEN, ATTEMPTED TO ADVANCE CATHETER OFF OF NEEDLE. CATHETER FELT AS IF IT GOT STUCK ON THE NEEDLE. ATTEMPTED TO RETRACT NEEDLE FROM CATHETER BUT SAFETY DEVICE WOULD NOT ACTIVATE. NEEDLE WAS MANUALLY RETRACTED AND CATHETER WAS ADVANCED SUCCESSFULLY. POSITIVE BLOOD RETURN AND CONFIRMED PLACEMENT. NEEDLE WOULD* RETRACT WITH SAFETY DEVICE AFTER IT WAS OUT OF THE PATIENT'S ARM". DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM TO PATIENT, BUT RISK TO CARE PROVIDER HAVING NO SAFETY ENGAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185157 ↗
• MalfunctionJan 15, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079052 ↗
• MalfunctionJan 15, 2026Retraction Problem

  1/5/2026: WHILE STARTING A LINE IN A PATIENT THE IV CATHETER NEEDLE WOULD NOT RETRACT AFTER PRESSING THE AUTOGUARD SAFETY BUTTON. 1/15/2026- CUSTOMER RESPONSE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO HEALTHCARE PROFESSIONAL INJURY OCCURRED. A PATIENT NEEDED AN IV INSERTED. THE PRODUCT MALFUNCTION RESULTED IN THE PATIENT BEING STUCK X4 FOR IV ACCESS. I BELIEVE EACH ADDITIONAL ATTEMPT OVER 1 WOULD BE CONSIDERED AN ADVERSE EVENT.

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

  MAUDE report 24079047 ↗
• MalfunctionJan 13, 2026Retraction Problem

  V THERAPY STAFF RN STARTED AN IV ON A PATIENT USING A 20G 1.16IN IV AND THE NEEDLE'S SAFETY MECHANISM, THE BUTTON TO RETRACT THE NEEDLE, WAS JAMMED. WHEN TRYING TO PHYSICALLY REMOVE THE NEEDLE FROM THE HUB AFTER INSERTION, I WAS THEN MET WITH SLIGHT RESISTANCE. AFTER REMOVAL FROM THE CATHETER, THE SAFETY STILL DIDN'T ACTIVATE TO RETRACT THE NEEDLE INTO THE CENTER OF THE IV. ADDITIONAL INFORMATION RECEIVED ON 09JAN2026 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? 12/22/2025. 2. WHAT WAS THE IMPACT TO THE PATIENT? IV START WAS OK, NO PT ISSUES. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056393 ↗
• MalfunctionJan 12, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032037 ↗
• MalfunctionJan 6, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973603 ↗
• MalfunctionDec 11, 2025Leak/Splash; Leak/Splash

  NO NEW INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783694 ↗
• MalfunctionDec 10, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768640 ↗
• MalfunctionDec 5, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733023 ↗
• MalfunctionDec 5, 2025Leak/Splash; Leak/Splash

  CUSTOMER RESPONSE ON (B)(6) 2025. FOR (B)(4): 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 10/28/2025 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? UNAVAILABLE 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM. IV LEAKED DURING CORONARY CTA SMALL AMOUNT OF SALINE. IV OPENED AT THE CONNECTION OF THE IV CATHETER AND TUBING, AREA UNDER THE TEGADERM IN THE RT AC. AFTER CONNECTING WITH THE CT AFTER WE SPOKE WITH YOU THIS AFTERNOON, IT TURNS OUT IT IS THE CONNECTION BETWEEN THE J-LOOP AND IV CATHETER SITE. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733017 ↗
• MalfunctionDec 4, 2025Retraction Problem; Retraction Problem

  DATE OF EVENT: 11/07/2025. CUSTOMER REPORTS THAT THE IV TEAM WAS CALLED TO ROOM TO START PVAD. STUDENT RN ATTEMPTING IV START AT BEDSIDE. ATTEMPT UNSUCCESSFUL. WHEN STUDENT RN ATTEMPTED TO RETRACT IV NEEDLE, WHITE BUTTON FOR RETRACTION WAS STUCK, AND THE NEEDLE WOULD NOT RETRACT. UNSAFE CONDITION TO KEEP NEEDLE FOR BD TO REVIEW AND UNRETRACTED NEEDLE WAS PLACED IN THE SHARPS BIN BY IV TEAM RN. HB. WAS PATIENT OR END-USER INJURED: N. WHEN WAS INCIDENT NOTICED: PRIOR TO USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: N. WAS ANY MEDICAL TREATMENT REQUIRED: N.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722311 ↗
• MalfunctionDec 3, 2025Leak/Splash; Leak/Splash

  LEAKING FROM CATHETER TO EXTENSION SET (CHANGED EXTENSION SET BUT ISSUE STILL PERSISTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708195 ↗

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-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-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-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-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-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-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-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