BD Insyte AutoguardRecalls & reported problems across all models

We found 33 models of BD Insyte Autoguard by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 4,465 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Sep 30, 2026 — classified as 166 injuries, 4,299 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (1,929 reports).

8 FDA recall records name at least one of these models by its device identifier, 8 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Insyte Autoguard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 21, 2025Open, Classified

   Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

   Z-2007-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

2. May 21, 2025Open, 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 ↗

3. May 21, 2025Open, Classified

   Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

   Z-2002-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

4. May 21, 2025Open, Classified

   Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

   Z-2001-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

5. May 21, 2025Open, Classified

   Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

   Z-2000-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

6. May 21, 2025Open, Classified

   Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

   Z-1999-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

7. Jun 26, 2024Open, Classified

   Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

   Z-2458-2024 · Root cause: Process control · Recall details · FDA record ↗

8. Oct 4, 2023Open, Classified

   Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

   Z-0400-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported BD Insyte Autoguard problems

BD Insyte Autoguard models

33 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Insyte Autoguard 382523

  Catheter,intravascular,therapeutic,short-term less than 30 days
  660 reports
• BD Insyte Autoguard 382533

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls527 reports
• BD Insyte Autoguard 381423

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall528 reports
• BD Insyte Autoguard 382544

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall437 reports
• BD Insyte Autoguard 381433

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall314 reports
• BD Insyte Autoguard 382534

  Catheter,intravascular,therapeutic,short-term less than 30 days
  359 reports
• BD Insyte Autoguard 381434

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall303 reports
• BD Insyte Autoguard 381412

  Catheter,intravascular,therapeutic,short-term less than 30 days
  294 reports
• BD Insyte Autoguard 382633

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall126 reports
• BD Insyte Autoguard 382512

  Catheter,intravascular,therapeutic,short-term less than 30 days
  149 reports
• BD Insyte Autoguard 381523

  Catheter,intravascular,therapeutic,short-term less than 30 days
  97 reports
• BD Insyte Autoguard 382623

  Catheter,intravascular,therapeutic,short-term less than 30 days
  91 reports
• BD Insyte Autoguard 381444

  Catheter,intravascular,therapeutic,short-term less than 30 days
  84 reports
• BD Insyte Autoguard 381533

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall34 reports
• BD Insyte Autoguard 381512

  Catheter,intravascular,therapeutic,short-term less than 30 days
  73 reports
• BD Insyte Autoguard 382644

  Catheter,intravascular,therapeutic,short-term less than 30 days
  62 reports
• BD Insyte Autoguard 381534

  Catheter,intravascular,therapeutic,short-term less than 30 days
  54 reports
• BD Insyte Autoguard 381467

  Catheter,intravascular,therapeutic,short-term less than 30 days
  48 reports
• BD Insyte Autoguard 382612

  Catheter,intravascular,therapeutic,short-term less than 30 days
  46 reports
• BD Insyte Autoguard 382634

  Catheter,intravascular,therapeutic,short-term less than 30 days
  44 reports
• BD Insyte Autoguard 381437

  Catheter,intravascular,therapeutic,short-term less than 30 days
  28 reports
• BD Insyte Autoguard 382554

  Catheter,intravascular,therapeutic,short-term less than 30 days
  22 reports
• BD Insyte Autoguard 381544

  Catheter,intravascular,therapeutic,short-term less than 30 days
  21 reports
• BD Insyte Autoguard 382537

  Catheter,intravascular,therapeutic,short-term less than 30 days
  17 reports
• BD Insyte Autoguard 381447

  Catheter,intravascular,therapeutic,short-term less than 30 days
  11 reports
• BD Insyte Autoguard 382547

  Catheter,intravascular,therapeutic,short-term less than 30 days
  10 reports
• BD Insyte Autoguard 381454

  Catheter,intravascular,therapeutic,short-term less than 30 days
  9 reports
• BD Insyte Autoguard 382557

  Catheter,intravascular,therapeutic,short-term less than 30 days
  6 reports
• BD Insyte Autoguard 382637

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• BD Insyte Autoguard 381457

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• BD Insyte Autoguard 381554

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• BD Insyte Autoguard 382647

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• BD Insyte Autoguard 382654

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report

Recent BD Insyte Autoguard adverse event reports

The 15 most recent reports across all models, 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 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954465 ↗
• MalfunctionSep 29, 2026Leak/Splash; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940848 ↗
• InjurySep 29, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50939012 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: Insufficient Information

  MAUDE report 50935976 ↗
• MalfunctionSep 23, 2026Retraction Problem

  It was reported that BD INSYTE AUTOG BC needle did not retract.Issue: A patient presented to IRU preoperatively for port placement. During peripheral IV insertion, a 20-gauge × 1-inch BD Insyte Autoguard BC catheter was used. After successful venipuncture, the white push-button mechanism designed to retract the needle did not function when activated. Additional information 14Sep2026:Can you please provide an exact date of event? 09SEP2026Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event. No injury or harm occurred to the patient or staff.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868156 ↗
• MalfunctionSep 16, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787133 ↗
• MalfunctionSep 9, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698883 ↗
• MalfunctionSep 1, 2026Material Integrity Problem

  Patient problems: Pain

  MAUDE report 50547357 ↗
• MalfunctionJul 1, 2026Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER HAS A HOLE IN IT. WE HAVE A LOT (#5188475) OF 22G CATHETERS THAT HAVE HOLES IN THEM. THE PATIENT'S BLOOD IS LEAKING OUT OF THE INSERTION SITE, HOWEVER, THE BLOOD CONTROL IS STILL IN TACT. SO THERE'S A HOLE IN THE TIP OF THE CATHETERS. CUSTOMER RESPONDED ON 17-JUN: THIS HAS HAPPENED ON MULTIPLE OCCASIONS, THE FIRST BEING (B)(6) 2026 AT 1000 AM. THE NEXT WAS MY COWORKER (B)(6) ON (B)(6) 2026, AND THE LAST ONE BEING (B)(6) 2026 WITH ME AGAIN. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2/3 PATIENTS WITH NEEDLE PHOBIA GOT FAINT AND LIGHTHEADED SEEING BLOOD RUN DOWN THEIR ARM OUT OF THE INSERTION SITE. AGAIN, THE BLOOD CONTROL IS INTACT, BUT THE LEAK APPEARED TO COME FROM A SMALL HOLE IN THE TIP OF THE PLASTIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682838 ↗
• MalfunctionJul 1, 2026Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER HAS A HOLE IN IT. WE HAVE A LOT (#5188475) OF 22G CATHETERS THAT HAVE HOLES IN THEM. THE PATIENT'S BLOOD IS LEAKING OUT OF THE INSERTION SITE, HOWEVER, THE BLOOD CONTROL IS STILL IN TACT. SO THERE'S A HOLE IN THE TIP OF THE CATHETERS. CUSTOMER RESPONDED ON 17-JUN THIS HAS HAPPENED ON MULTIPLE OCCASIONS, THE FIRST BEING (B)(6) 2026 AT 1000 AM. THE NEXT WAS MY COWORKER, (B)(6) ON (B)(6) 2026, AND THE LAST ONE BEING (B)(6) 2026 WITH ME AGAIN. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2/3 PATIENTS WITH NEEDLE PHOBIA GOT FAINT AND LIGHTHEADED SEEING BLOOD RUN DOWN THEIR ARM OUT OF THE INSERTION SITE. AGAIN, THE BLOOD CONTROL IS INTACT, BUT THE LEAK APPEARED TO COME FROM A SMALL HOLE IN THE TIP OF THE PLASTIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682833 ↗
• MalfunctionJun 29, 2026Premature Activation; Retraction Problem

  DATE OF EVENT AND NUMBER OF OCCURRENCES 1/26/2026 PRODUCT DETAILS (MATERIAL AND LOT NUMBER) 5267705 DESCRIPTION OF THE ISSUE OBSERVED: NEEDLE RETRACTED PRIOR TO ACTIVATION PATIENT IMPACT (IF KNOWN) NONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660772 ↗
• MalfunctionJun 26, 2026Air/Gas in Device

  IT WAS REPORTED THAT BD INSYTE AUTOG BC WING DREW AIR DURING ASPIRATION. WE HAD MULTIPLE INCIDENTS WITH THE 20G IV CATHETERS WHERE WE WILL PLACE THE IV, BUT AS WE ARE TRYING TO DRAW BLOOD INTO A SYRINGE OR J LOOP, IT PULLS MOSTLY AIR. THE HUBS OF THE IV CATHETERS DO NOT LOOK CRACKED. POSSIBLY THE SEAL BETWEEN THE CATHETERS AND THE HUBS ARE COMPROMISED. NO PATIENT IMPACT/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637154 ↗
• MalfunctionJun 25, 2026Material Frayed

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER WAS FRAYED. RN WENT TO START PIV WITH 22G PIV NEEDLE/CATHETER, THE NEEDLE BARELY PENETRATED THE SKIN AND THE CATHETER WOULD NOT GO INTO THE SKIN. THIS RN RETRACTED THE NEEDLE TO DISCOVER THE CATHETER WAS FRAYED AND SQUARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626468 ↗
• 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 ↗

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