BD Insyte-N AutoguardRecalls & reported problems across all models

We found 4 models of BD Insyte-N Autoguard by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 377 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Aug 31, 2026 — classified as 22 injuries, 355 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (82 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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-N 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-2004-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported BD Insyte-N Autoguard problems

BD Insyte-N Autoguard models

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

• BD Insyte-N Autoguard 381411

  Catheter,intravascular,therapeutic,short-term less than 30 days
  154 reports
• BD Insyte-N Autoguard 381511

  Catheter,intravascular,therapeutic,short-term less than 30 days
  148 reports
• BD Insyte-N Autoguard 381811

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall66 reports
• BD Insyte-N Autoguard 381911

  Catheter, intravascular, therapeutic, short-term less than 30 days
  9 reports

Recent BD Insyte-N Autoguard adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528843 ↗
• MalfunctionJun 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED CATHETER HAD JAGGED OR SHREDDED EDGES. DESCRIPTION OF THE ISSUE(S) OBSERVED: ALL DESCRIBED DIFFICULTY ADVANCING CATHETER AND JAGGED, OR SHREDDED CATHETER EDGES ANY PATIENT IMPACT OR ADVERSE EVENTS: PATIENTS REQUIRED ADDITIONAL NEEDLE STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669502 ↗
• MalfunctionJun 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED BY A CUSTOMER THAT THE CATHETER WAS OBSERVED TO SHRED OR TEAR AT THE INSERTION SITE DURING THE PROCEDURE. WAS LOT # 6016974 ALSO AFFECTED? YES IS A NEW COMPLAINT RECORD NEEDED FOR THE SAMPLE LOT # 6016974 RECEIVED? THIS WAS INCLUDED ON OUR END, HOWEVER IF YOU DO NOT HAVE A COMPLAINT ON YOUR END THEN YES. IT WILL BE THE SAME INFORMATION AND SAME CONCERNS AS THE PREVIOUS. INFORMATION FROM PREVIOUS: IT WAS REPORTED BY A CUSTOMER THAT THE CATHETER WAS OBSERVED TO SHRED OR TEAR. THESE INSIGHTS ARE WHAT WE USE IN THE NICU TO START IVS. UNFORTUNATELY, WE HAVE HAD A COUPLE NOW THAT SPLIT WHEN YOU TRY TO INSERT WHICH CAUSES THE VEIN TO BLOW. ADDITIONAL INFORMATION RECEIVED ON 31MAR2026: ON (B)(6) 2026, TWO ADDITIONAL INSIGHT DEVICES WERE USED¿ONE BY AN RN AND ONE BY AN NNP. IN BOTH CASES, THE CATHETER WAS OBSERVED TO SHRED OR TEAR AT THE INSERTION SITE DURING THE PROCEDURE. PLEASE SPECIFY THE NUMBER OF PATIENTS INVOLVED AND CONFIRM WHETHER BOTH NEEDLE SPLITS OCCURRED WITH A SINGLE PATIENT? TWO SEPARATE PATIENTS INVOLVED, SEPARATE DATES AND TIMES WITH DIFFERENT STAFF INVOLVED. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE

  Patient problems: Perforation of Vessels

  MAUDE report 25448126 ↗
• MalfunctionJun 8, 2026Material Frayed

  FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: 5/15/26 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436166 ↗
• MalfunctionJun 8, 2026Material Frayed

  FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: (B)(6) 2026 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436165 ↗
• MalfunctionJun 8, 2026Material Frayed

  FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: 5/15/26. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436161 ↗
• MalfunctionJun 4, 2026Material Integrity Problem

  VERBATIM: WHILE XXXX WAS TRYING TO PLACE IV ON INFANT, XXX NOTICED THAT THE IV CATHETER WAS BEGINNING TO SHRED. WE BOTH STOPPED HIM BEFORE HE PUT IV IN INFANT'S ARM. AFTER THAT ALL IV CATHETERS WITH THOROUGHLY INSPECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402251 ↗
• MalfunctionJun 2, 2026Material Frayed

  IN MULTIPLE CASES, THE CANNULA IS SPLITTING AND WILL NOT THREAD INTO THE VEIN, OR IT FRAYS AFTER PASSING THROUGH THE DERMIS. THESE FAILURES ARE RESULTING IN SIGNIFICANT AND UNNECESSARY INSERTION ATTEMPTS AND ARE LEADING TO BLOWN VEINS IN OUR NEONATAL POPULATION.

  Patient problems: Perforation of Vessels

  MAUDE report 25366667 ↗
• MalfunctionJun 2, 2026Material Split, Cut or Torn

  IN MULTIPLE CASES, THE CANNULA IS SPLITTING AND WILL NOT THREAD INTO THE VEIN, OR IT FRAYS AFTER PASSING THROUGH THE DERMIS. THESE FAILURES ARE RESULTING IN SIGNIFICANT AND UNNECESSARY INSERTION ATTEMPTS AND ARE LEADING TO BLOWN VEINS IN OUR NEONATAL POPULATION.

  Patient problems: Perforation of Vessels

  MAUDE report 25366654 ↗
• MalfunctionJun 1, 2026Material Frayed

  WHEN TRYING TO INSERT A PERIPHERAL IV ON OUR PATIENT FOR HYPOGLYCEMIA WE HAD 3 IV CATHETERS WITH FRAYED ENDS, CAUSING THE IV START TO BE UNSUCCESSFUL OR BLOW THE VEIN.

  Patient problems: Perforation of Vessels

  MAUDE report 25351802 ↗
• MalfunctionMay 21, 2026Material Puncture/Hole; Retraction Problem; Material Integrity Problem

  IT IS REPORTED THAT NEEDLE RETRACTION ISSUES ARE LEADING TO NEEDLE PIERCING THE CATHETER. STAFF STATE IT IS DRAGGING AND IF THEY HAVE TO PULL OUT A BIT AT ALL IT PUNCTURES THE PLASTIC PART. THEY SAID THE BABIES ARE BEING STUCK MULTIPLE TIMES DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243833 ↗
• MalfunctionMay 15, 2026Product Quality Problem

  IT WAS REPORTED THAT THE NEEDLE HUB HAD A SHARPNESS. "CUSTOMER PLACED 24 X 0.75 PIVC IN XXX PATIENT - CORRECT PROCESS AND PROCEDURE WAS FOLLOWED. CUSTOMER MENTIONED THAT THERE WAS A PRESSURE WOUND FROM BD PIVC AS THERE WAS A SHARPNESS ON THE CATHETER HUB.".

  Patient problems: Unspecified Skin and Subcutaneous Tissue Problem

  MAUDE report 25184569 ↗
• MalfunctionApr 30, 2026Leak/Splash; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044845 ↗
• MalfunctionApr 22, 2026Material Puncture/Hole

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955100 ↗
• MalfunctionApr 13, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865227 ↗

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