BD Insyte-N Autoguard 381511Recalls & reported problems
Becton, Dickinson And Company · INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN · Class 2
All models of BD Insyte-N Autoguard (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte-N Autoguard winged IV catheter is a short-term tube placed in a vein for fluids or medicines. Many reports describe catheter tips that fray or shred, making insertion difficult, and some describe the needle not retracting. The 155 reports include no deaths and 11 injuries. No recalls name this device, and reports rose from 9 in the prior 12 months to 26 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00382903815111), received between Jul 14, 2017 and Aug 31, 2026 — classified as 11 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (31 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash31
- Material Split, Cut or Torn31
- Device Contamination with Chemical or Other Material20
- Material Frayed18
- Retraction Problem14
- Break13
- Material Puncture/Hole10
- Defective Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions101
- No Known Impact Or Consequence To Patient18
- Insufficient Information9
- No Consequences Or Impact To Patient7
- Perforation of Vessels6
- Foreign Body In Patient3
- No Code Available3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 148 reports, 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 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 ↗MalfunctionApr 10, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845630 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845333 ↗MalfunctionApr 9, 2026Material Split, Cut or Torn
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 EVENT. PATIENTS REQUIRED MULTIPLE STICKS AS TEAR IN CATHETER CAUSED VEIN TO RUPTURE.
Patient problems: Perforation of Vessels
MAUDE report 24835162 ↗MalfunctionApr 9, 2026Material Split, Cut or Torn
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 EVENT. PATIENTS REQUIRED MULTIPLE STICKS AS TEAR IN CATHETER CAUSED VEIN TO RUPTURE.
Patient problems: Perforation of Vessels
MAUDE report 24835159 ↗MalfunctionMar 5, 2026Material Integrity Problem
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521625 ↗MalfunctionJan 21, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24140296 ↗MalfunctionDec 9, 2025Material Integrity Problem; Material Integrity Problem
CUSTOMER RESPONSE (B)(6) 2025. "THE ONLY INFORMATION PROVIDED WAS THAT THE CATHETER TIPS WERE ROUGH AND CAUSING SKIN TEARS RATHER THAN SMOOTH INSERTIONS.".
Patient problems: Insufficient Information; Skin Tears
MAUDE report 23761952 ↗MalfunctionDec 9, 2025Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
1.WAS THERE ANY HARM/SERIOUS INJURY TO THE PATIENT? IF YES, PLEASE DESCRIBE IN FULL DETAIL.NO HARM REPORTED ON THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23759720 ↗MalfunctionNov 21, 2025Material Frayed; Material Frayed
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621697 ↗MalfunctionNov 21, 2025Material Frayed; Material Frayed
RN ATTEMPT X2 TO PLACE PIV USING 24GAUGE 0.56IN CATHETER BD INSYTE-N AUTOGUARD LOT 3114869, EXP 3/31/2026 AND LOT 2021385, EXP 1/31/2028. BOTH TIMES THE CATHETER TIP WAS SPLIT AND FRAYED. RESULTING IN 3 IV STICKS FOR THIS INFANT. SWITCHED TO 26GAUGE CATHETER WITHOUT INCIDENT. I SPOKE WITH (B)(6) AND HE THOUGHT THEY WERE FRAYED BEFORE INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621692 ↗MalfunctionNov 12, 2025Connection Problem; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539349 ↗MalfunctionSep 4, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22969133 ↗MalfunctionSep 3, 2025Retraction Problem; Retraction Problem
ISSUE: ¿THE NEEDLE DID NOT PROPERLY RETRACT WHEN THE SAFETY BUTTON WAS PRESSED DURING IV INSERTION ON NEONATE. CUSTOMER RESPONSE ON 21-AUG-2025. 8/18/2025. NO INJURY OR COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958433 ↗MalfunctionAug 28, 2025Defective Device; Defective Device
IT IS REPORTED CATHETER NOTICED TO BE SPLITTING. EVENT DESCRIPTION: MATERIAL 381511. LOT 3340243. IV ACCESS NEEDED FOR INFANT. 3 RNS TRIED, 3X THERE WERE ISSUES ADVANCING CATHETER- UPON EXAMINATION- CATHETER WAS NOTICED TO BE SPLITTING. ENTIRE BATCH WITH LOT 3340243 REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912688 ↗MalfunctionAug 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835408 ↗MalfunctionMay 28, 2025Material Perforation; Premature Separation; Material Perforation; Premature Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101685 ↗MalfunctionMay 28, 2025Material Perforation; Premature Separation; Material Perforation; Premature Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101110 ↗
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, ClassifiedREF: 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-2002-2025 · May 21, 2025 · Open, ClassifiedREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
- Z-2000-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2005-2025 · May 21, 2025 · Open, ClassifiedREF: 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, ClassifiedREF: 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-2001-2025 · May 21, 2025 · Open, ClassifiedREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
- Z-2007-2025 · May 21, 2025 · Open, ClassifiedREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Z-1999-2025 · May 21, 2025 · Open, ClassifiedREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
- Z-2006-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2458-2024 · Jun 26, 2024 · Open, ClassifiedBD 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, ClassifiedBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page