BD Insyte Autoguard 382523Recalls & reported problems

Summary

The FDA's MAUDE database contains 660 adverse event reports that list this exact device (DI 00382903825233), received between Oct 26, 2017 and Sep 1, 2026 — classified as 15 injuries, 645 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (195 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 660 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Integrity Problem

  Patient problems: Pain

  MAUDE report 50547357 ↗
• MalfunctionJun 25, 2026Leak/Splash

  IT WAS REPORTED THAT INSYTE AUTOG BC LEAKED BEYOND THE SEPTUM. CUSTOMER PURCHASED THE 22G WINGLESS AND BLOOD CONTROLLING IV CATHETERS. THE LAST CLIENT OF THE DAY I PLACED IV FROM THE SAME BOX THAT I HAD BEEN USING ALL DAY WITH NO ISSUES HOWEVER THIS ONE WAS NOT BLOOD CONTROLLING, AND BLOOD WAS POURING T FROM THE IV. THIS CLIENT IS SENSITIVE TO NEEDLES, AND THIS PUT A POUR TASTE IN HIS MOUTH. XXXX DOUBTED THE SERVICE THAT I COULD PROVIDE AND WANTED TO DISCONTINUE BEFORE STARTING THE DRIP. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622909 ↗
• MalfunctionJun 23, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC FEELS FLIMSY. VERBATIM: NEEDLES AREN¿T SHARP AND REQUIRES MORE FORCE WHILE INSERTING WHICH CAUSES PAIN TO THE PATIENT. CATHETER DOES NOT THREAD WELL, FEELS VERY FLIMSY. MACHINE PRESSURES OUT WHILE INJECTING.

  Patient problems: Pain

  MAUDE report 25598897 ↗
• MalfunctionJun 10, 2026Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. EVENT DETAILS: VERBATIM: ACCORDING TO THE REPORT, THE BLUE CATHETER REMAINED IN THE IV SET KIT WHILE NEEDLE WAS BEING REMOVED AND THE SAFETY BUTTON DEVICE ALSO MALFUNCTIONED. THE IV NEEDLE WAS NOT USED AND WE HAVE THE PRODUCT IF NEEDED. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461237 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368353 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL: THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER: THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED: THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS: Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368352 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368350 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368349 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368345 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368344 ↗
• MalfunctionJun 2, 2026Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368343 ↗
• MalfunctionJun 2, 2026Retraction Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25362964 ↗
• MalfunctionJun 1, 2026Retraction Problem

  DESCRIPTION AS REPORTED: WE HAVE ORDERED THIS ITEM CONTINUOUSLY STARTING ON (B)(6) 2026 AND HAVE HAD A FEW ISSUES SINCE RECEIVING THEM. IN ONE INSTANCE, THE SAFETY NEEDLE WOULD NOT ENGAGE AT ALL. IN ANOTHER INSTANCE, THE SAFETY NEEDLE ENGAGED HALFWAY. I DO NOT HAVE SPECIFIC DATES ONCE WE ANNOUNCED THIS OTHER NURSES CAME FORWARD WITH SIMILAR ISSUES NO HARM TO PATIENT OR EMPLOYEE IN ANY INSTANCE I JUST HAD A NURSE WITH AN IV WHERE THE SAFETY NEEDLE FEATURE WOULD NOT ENGAGE AT ALL. SHE SAID THE BUTTON WOULD NOT MOVE AT ALL.

  Patient problems: Insufficient Information

  MAUDE report 25356284 ↗
• MalfunctionJun 1, 2026Leak/Splash; Material Puncture/Hole

  STARTED LEAKING DURING THE BLOOD RETURN OF THE INITIAL IV STICK. NOTHING INJECTED. VISIBLE LEAK FROM A HOLE IN THE SHEATH. PICS ATTACHED. NO DIFFICULTY WITH THE IV STICK. WAS THERE HARM TO PATIENT OR DEVICE USER? IF YES, PLEASE DESCRIBE. WHAT WAS DONE TO COMPLETE THE PROCEDURE? HAD TO RE STICK THE PATIENT WITH ANOTHER NEEDLE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352604 ↗
• MalfunctionMay 29, 2026Shielding Failure

  "TO CLARIFY THE ISSUE, AFTER I INSERTED THE CATHETER AND REMOVED THE NEEDLE, THE SAFETY BUTTON APPEARED TO BE STUCK. THIS PREVENTED THE NEEDLE FROM RETRACTING FULLY INTO THE SAFETY HOUSING AS INTENDED." ADDITIONAL INFORMATION: THE EVENT OCCURRED ON 05/05/2026.

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

  MAUDE report 25339981 ↗
• MalfunctionMay 27, 2026Leak/Splash

  IT IS REPORTED THAT LEAKAGE OCCURS. ITEM LEAKS FROM THE SIDE ONCE THE NURSE INSERTS THE IV CATH INTO THE PATIENT, THERE ARE NO REPORTED INJURIES OTHER THAT THE DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25307137 ↗
• MalfunctionMay 27, 2026Retraction Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE NEEDLES ARE NOT RETRACTING WHEN PUSHING THE WHITE BUTTON. THE WHITE BUTTON DID NOT RETRACT THE NEEDLE ON 2 OCCASIONS. WHEN THE USER PRESSED THE RETRACTION BUTTON DID THE NEEDLE MOVE AT ALL? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE ONLY RETRACT PART WAY AND GET STUCK WITHIN THE CATHETER? THE NEEDLE DID NOT RETRACT AT ALL. DID THE NEEDLE RETRACT SLOWER THAN EXPECTED? THE NEEDLE DID NOT RETRACT AT ALL. DID THESE INSTANCES HAPPEN WITH DIFFERENT PATIENTS? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303217 ↗
• MalfunctionMay 21, 2026Activation Failure; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. INJURIES OR ADVERSE EVENT: NO. PIV, NEEDLE WOULD NOT RETRACT CAUSING SHARP TO BE EXPOSED AND ADDITION PIV PLACED. THE DATE OF THE EVENT IS (B)(6) 2026. I'VE ATTACHED TO PHOTO THAT WAS PROVIDED BY THE UNIT BELOW, BUT IT IS BLURRY AND HARD TO SEE THE LOT# CLEARLY. ACCORDING TO THE REPORTING NURSE SHE COULD NOT DEPRESS THE ACTIVATION BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243470 ↗
• MalfunctionMay 21, 2026Product Quality Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS NO FLASHBACK AND THE CATHETER WAS BENT. INJURIES OR ADVERSE EVENT: NO TIP OF IV CATHETER APPEARS BENT WITH NO BLOOD RETURN IT WAS FOUND ON THE INVESTIGATION THAT THE NEEDLE PIERCED THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242070 ↗
• MalfunctionMay 15, 2026Retraction Problem

  IT WAS REPORTED THA THE NEEDLE DID NOT RETRACT. HAPPENED ON 02/27/2026). HARM LEVEL-NO HARM. DID REACH PATIENT/PERSON: NOTES FROM THE REPORTING NURSE- WHEN PLACING PIV, NEEDLE WOULD NOT RETRACT CAUSING SHARP TO BE EXPOSED AND ADDITION PIV PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187265 ↗
• MalfunctionMay 12, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE CATHETER. "GOOD MORNING, ONE OF OUR NURSES OPENED AN IV CATHETER AND NOTICED THAT THERE WAS SOMETHING INSIDE THE CAP. I TOOK IT OUT AND IT SEEMS TO HAVE WHAT LOOKS LIKE A PLASTIC STRING ON THE TIP AND AT THIS TIME WE HAVE NOT FOUND ANYMORE, PLEASE SEE PICTURES BELOW." CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 27-04-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148262 ↗
• MalfunctionApr 29, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028584 ↗
• MalfunctionApr 29, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028583 ↗
• MalfunctionApr 28, 2026Leak/Splash

  IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE DID NOT WORK. A CUSTOMER REACHED OUT TO LET US KNOW THAT ITEMS 382537 AND 382523 ARE HAVING ISSUES WITH BLOOD CONTROL. ALTHOUGH BOTH ITEMS ARE LABELED AS BLOOD CONTROL, IT WAS REPORTED THAT BLOOD WAS GETTING EVERYWHERE DURING USE. THE LOT NUMBERS AND EXPIRATION DATES FOR THE ITEMS IN QUESTION ARE BELOW. PLEASE ADVISE ON HOW TO PROCEED. NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED ADDITIONAL INFORMATION: (B)(6) 2026 AND AGAIN ON (B)(6) 2026 NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019825 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE DID NOT WORK. A CUSTOMER REACHED OUT TO LET US KNOW THAT ITEMS 382537 AND 382523 ARE HAVING ISSUES WITH BLOOD CONTROL. ALTHOUGH BOTH ITEMS ARE LABELED AS BLOOD CONTROL, IT WAS REPORTED THAT BLOOD WAS GETTING EVERYWHERE DURING USE. THE LOT NUMBERS AND EXPIRATION DATES FOR THE ITEMS IN QUESTION ARE BELOW. PLEASE ADVISE ON HOW TO PROCEED. NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000934 ↗

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, 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-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-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-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-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-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-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-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