BD Insyte Autoguard 381437Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD PNK 20GA X 1.88IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard is a short-term IV catheter with a safety needle that is meant to retract automatically after the needle is withdrawn from a blood vessel. Most of the 28 reports describe that retraction failing, with the needle stuck inside the catheter and in some cases splitting or fraying the tubing, plus some leaking from the hub and one report of the catheter getting caught in tissue. Reports mention one injury and no deaths. There are no recalls naming this device.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382903814374), received between Nov 10, 2017 and Jun 1, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (14 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
- Retraction Problem14
- Leak/Splash3
- Break2
- Material Frayed2
- Material Split, Cut or Torn2
- Expiration Date Error1
- Material Integrity Problem1
- Material Perforation1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- No Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Material Frayed
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351803 ↗MalfunctionFeb 6, 2026Nonstandard Device
DURING IVS, THE NEEDLE BECAME STUCK IN THE CATHETER AND HAD TO BE REMOVED FROM THE PATIENT. THE NEEDLE APPEARED TO HAVE BEEN CAUGHT ON THE PORTION OF THE CATHETER. SERIOUS INJURY: NO. DEATH: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279240 ↗MalfunctionNov 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD PNK 20GA X 1.88IN HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 381437, BATCH#: 5115172. IT WAS REPORTED BY CUSTOMER THAT POTENTIAL LEAKING FROM HUB OF INSYTE AUTOGUARD. POTENTIAL LEAKING FROM HUB OF IAG NONBC WITH EXT SET ATTACHED. HAD TO PULL AND PLACE A NEW LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23500983 ↗MalfunctionOct 21, 2025Retraction Problem; Material Integrity Problem; Retraction Problem; Material Integrity Problem
IT WAS REPORTED TO ME BY ****** THAT ON (B)(6) 2025 ON OUR *****, BD ITEM: 381437 WAS FAULTY: ¿IV ANGIO CATHETER WAS ATTEMPTED INSERTION UNDER ULTRASOUND GUIDANCE. PLACEMENT WAS CONFIRMED VIA ULTRASOUND AND WITH BLOOD IN ANGIO CATHETER CHAMBER. UPON RETRACTION OF NEEDLE, THE NEEDLE BECAME STUCK AND SPLIT THE CATHETER AT THE PINK LUER HUB. NO HARM WAS DONE TO THE PATIENT, AS TECHNIQUE WAS PULLING BACK ON THE NEEDLE, WHILE SLIDING ANGIO CATHETER INTO THE PATIENT.¿ NO HARM CAME TO THE PATIENT DUE TO EXPERT NURSING CARE. ADDITIONAL QUESTIONS YOU MAY HAVE SHOULD BE DIRECTED TO ****.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23344570 ↗MalfunctionAug 1, 2025Material Perforation; Material Perforation
MalfunctionDec 4, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STAFF MEMBER WAS TRYING TO PLACE A 20G PERIPHERAL IV IN A PATIENT, BUT WHEN INSERTED, THE NEEDLE WOULD NOT RETRACT. THE WHITE BUTTON ON THE DEVICE WAS STUCK AND THE NEEDLE COULD NOT BE RETRACTED. THEREFORE, IT WAS REMOVED AND ANOTHER ONE HAD TO BE USED RESULTING IN TWO POKES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846996 ↗MalfunctionJun 24, 2024Retraction Problem; Retraction Problem
MalfunctionJun 21, 2024Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580015 ↗MalfunctionMay 21, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE WILL NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WILL NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367274 ↗MalfunctionMar 25, 2024Retraction Problem; Retraction Problem
DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. NONE REPORTED. PLEASE CONFIRM THE NUMBER OF OCCURRENCE. 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970875 ↗MalfunctionNov 18, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18166786 ↗InjurySep 2, 2023Break; Break
IT WAS REPORTED THAT WHILE USING THE IT SEPARATED AND REMAINED IN PATIENTS ARM REQUIRING SURGICAL REMOVAL. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: DESCRIBE THE EVENT OR PROBLEM: REGISTERED NURSE (RN) ATTEMPTING IV PLACEMENT IN ANTECUBITAL FOSSA OF RIGHT ARM. RN WAS USING ULTRASOUND GUIDANCE. RN WAS UNABLE TO GET THE CATHETER INTO THE VEIN, SO BEGAN WITHDRAWING THE CATHETER. UPON REMOVAL OF THE CATHETER, RN NOTICED THAT THE ACTUAL CATHETER HAD DETACHED FROM THE NEEDLE, AND THE TIP OF THE PLASTIC CATHETER REMAINED IN THE ARM. PATIENT WENT TO SURGERY THE FOLLOWING DAY TO HAVE THE RETAINED PORTION OF THE CATHETER REMOVED. PATIENT WAS DISCHARGED HOME THAT SAME DAY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17674812 ↗MalfunctionApr 5, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BENT IN THE PATIENT'S ARM DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN NOTICED THAT HER SKIN LOOKED RAISED WHERE THE CATHETER WAS. WHEN RN REMOVED THE CATHETER, THE CATHETER WAS BENT IN TWO PLACES IN THE PATIENTS ARM. THIS WAS A 20G ULTRASOUND IV. RN REMOVED THE CATHETER, SAVED IT AND HANDED IT TO DIRECTOR. A SEPARATE IV WAS PLACED TO FINISH THE MED PASS.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685813 ↗MalfunctionApr 5, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RN WENT TO GIVE PATIENT IV LASIX. WHEN PUSHING THE LASIX IT WAS NOTED BY RN THAT THE CATHETER WAS LEAKING. RN WENT TO CHANGE THE DRESSING AND ADJUST THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685714 ↗MalfunctionDec 6, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT AFTER THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE FAILED TO RETRACT FROM IV AFTER INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15922053 ↗MalfunctionOct 26, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COWORKER HAS EXPERIENCED A PIV CATHETER WITH THE NON-RETRACTING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677194 ↗MalfunctionOct 20, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD 2 INSTANCES WHERE THE ABOVE NEEDLE DID NOT RETRACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15643237 ↗MalfunctionOct 20, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD 2 INSTANCES WHERE THE ABOVE NEEDLE DID NOT RETRACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15643229 ↗MalfunctionJun 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PRODUCT FAIL ON A PATIENT AND NEED TO REPLACE THE IV CATH , PRODUCT WAS SPLIT ON THE TUBE DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14809884 ↗MalfunctionJun 6, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE PUNCTURE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECEIVED ANOTHER IV CATHETER WITH A SIMILAR ISSUE. THIS ISSUE WAS NOTICED AFTER USE. NO HARM TO THE PATIENT THAT WE'RE AWARE OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14602724 ↗MalfunctionMay 20, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO ACTIVATE AND RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY NOT ACTIVATING ON DEVICE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14461803 ↗MalfunctionMar 25, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ULTRASOUND IV 20 GAUGE NEEDLE WOULD NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13906487 ↗MalfunctionOct 10, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.88IN (1.1 X 48 MM) EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY ATTEMPTED TO PLACE A 2ND IV IN A PATIENT WITH U/S AND DRAW THE 2ND SET OF CULTURES AND GOT GOOD BLOOD RETURN BUT NOTED THAT THERE BUBBLES NOTED IN END OF CATHETER WHILE DRAWING BLOOD. I SENT OFF THE CULTURES AND UPON FLUSHING THE IV 1.88""IT WAS NOTED THAT THERE WAS A LEAK WHERE THE PINK PART OF THE ANGIOCATH AND THE CATHETER MEET. I PULLED THE IV AND THERE WAS NOT INFILTRATION BECAUSE THE PART THAT WAS LEAKING WAS ON THE OUTSIDE OF THE SKIN. THE IV IN QUESTION IS A BD INSYTE AUTOGUARD 20GA X 1.88 IN. REF 381437, 00382903814374, LOT 0021768, EXP 2022-12-31.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10659912 ↗MalfunctionFeb 24, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT FROM THE VEIN DURING USE WHEN THE BUTTON WAS PRESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE DID NOT RETRACT WHEN BUTTON HIT AFTER INSERTED INTO VEIN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9746327 ↗MalfunctionMay 6, 2019Retraction Problem
MATERIAL NO.: 381437, BATCH NO.: 8117765. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER MW FORM: AFTER PLACING #22G 1.88" PIV, NEEDLE WOULD NOT RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8584464 ↗
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-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-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-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-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-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-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-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-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-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.
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