BD Insyte Autoguard 381434Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD PNK 20GA X 1.16IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Insyte Autoguard IV catheter is a catheter placed in a blood vessel. Many of the 303 reports describe the safety needle not retracting properly, along with fluid leaks and catheters splitting. The reports include 18 injuries and no deaths. There is 1 open recall, started in May 2025, over the needle possibly retracting slowly or failing to retract. Reports fell from 32 in the prior 12 months to 9 in the most recent 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
- 303
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 00382903814343), received between Oct 17, 2017 and Mar 18, 2026 — classified as 18 injuries, 285 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (165 reports).
1 FDA recall record name this device's identifier, 1 still open.
10 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
Recalls naming this device
- May 21, 2025Class IIOpen, 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 ↗
Most reported problems
Device problems
- Retraction Problem165
- Leak/Splash54
- Device Contamination with Chemical or Other Material28
- Material Protrusion/Extrusion16
- Break14
- Defective Component9
- Defective Device7
- Material Puncture/Hole6
Patient problems
- No Clinical Signs, Symptoms or Conditions177
- No Known Impact Or Consequence To Patient75
- No Consequences Or Impact To Patient18
- Insufficient Information16
- Needle Stick/Puncture9
- No Information5
- Foreign Body In Patient4
- No Code Available4
Recent adverse event reports
The 25 most recent of 303 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Nonstandard Device
IT WAS REPORTED THAT THE CATHETER SPLIT. INJURIES OR ADVERSE EVENT: NO REPORTED ISSUE: WE HAD ONE OF THE BELOW B-D381434 IV CATHS SPLIT THIS MORNING. UNSURE IF IT WAS USER ERROR OR A LOT NUMBER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630339 ↗MalfunctionMar 16, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607729 ↗MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material
THERE WAS A THIN PIECE OF METAL HANGING OFF THE TIP OF THE METAL IV INSERT. THIS WILL BE KEPT IN MY OFFICE IF ANYONE WANTS TO SEE. IT WAS NOT CAUGHT AND NOT USED. NO HARM TO ANY PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24124181 ↗MalfunctionDec 27, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901554 ↗MalfunctionDec 17, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832082 ↗MalfunctionNov 19, 2025Retraction Problem; Retraction Problem
IV CATHETER DID NOT RETRACT PROPERLY, NEEDLE ONLY RETRACTED 1/2 WAY. NO INJURIES, RN CAUGHT WHEN TRIED TO RETRACT IV NEEDLE AFTER IV INSERTED INTO PATIENT, DISCARDED CATHETER IN SHARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598692 ↗MalfunctionNov 18, 2025Retraction Problem; Retraction Problem
ACTIVATION OF THE SAFETY MECHANISM HAS BEEN ATYPICAL-THE NEEDLE RETRACTED VERY SLOWLY WITH DIFFICULTY. THE DEVICES THAT FAILED WERE DISCARDED DUE TO SAFETY CONCERNS; HOWEVER, UNUSED PRODUCT WITH THE SAME IDENTIFIERS WERE PULLED FROM THE SHELF AND ARE AVAILABLE FOR BD¿S INVESTIGATION. NO PATIENTS OR STAFF MEMBERS WERE INJURED WITH EITHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589470 ↗MalfunctionNov 18, 2025Retraction Problem; Retraction Problem
ACTIVATION OF THE SAFETY MECHANISM HAS BEEN ATYPICAL. THE NEEDLE DID NOT RETRACT ALL THE WAY. THE DEVICES THAT FAILED WERE DISCARDED DUE TO SAFETY CONCERNS; HOWEVER, UNUSED PRODUCT WITH THE SAME IDENTIFIERS WERE PULLED FROM THE SHELF AND ARE AVAILABLE FOR BD¿S INVESTIGATION. NO PATIENTS OR STAFF MEMBERS WERE INJURED WITH EITHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589255 ↗MalfunctionNov 17, 2025Activation Problem; Activation Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567968 ↗MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375889 ↗MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375888 ↗MalfunctionOct 23, 2025Retraction Problem; Retraction Problem
WE HAVE RECENTLY RECEIVED REPORTS THAT THE ITEM HAS BEEN TOUGHER TO RETRACT, WHICH COULD POTENTIALLY CAUSE A SAFETY ISSUE. THEY HAD MENTIONED THAT THIS DIDN¿T HAPPEN EVERY TIME, BUT IT HAS HAPPENED OFTEN ENOUGH TO WARRANT DISCUSSION. ISSUE WAS REPORTED OUT FROM CLINICAL STAFF ON (B)(6) 2025. WERE PREVIOUS COMPLAINTS REPORTED TO BD EARLIER? IF NOT KINDLY PROVIDE FURTHER DETAILS OF THE EVENTS. NO COMPLAINTS WERE LOGGED PRIOR TO THIS TIME. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NEEDLE DID FULLY RETRACT. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NEEDLE RETRACTED SLOWER THAN USUAL (THE REPORTED CONCERN). DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? NOT AN ISSUE THAT I WAS MADE AWARE OF. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? NOT AN ISSUE THAT I WAS MADE AWARE OF. DID THE BUTTON DEPRESS? NOT AN ISSUE THAT I WAS MADE AWARE OF. WAS THERE ANY HARM/SERIOUS INJURY TO THE PATIENT OR HCP DIRECTLY RELATED TO THIS REPORTED EVENT? CUSTOMER RESPONSE ON (B)(6) 2025. THERE WERE NO REPORTED INCIDENTS, THE STAFF WAS JUST CONCERNED ABOUT THE POSSIBILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364479 ↗MalfunctionOct 23, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364476 ↗MalfunctionSep 10, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017643 ↗MalfunctionSep 2, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22947893 ↗MalfunctionAug 15, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819653 ↗MalfunctionAug 15, 2025Retraction Problem; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE: JAN-25. ISSUE: RETRACTION ISSUES.
Patient problems: Insufficient Information
MAUDE report 22816970 ↗MalfunctionAug 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO HARM TO PATIENT. EVENT SUMMARY: IV WAS STARTED ON PATIENT. WENT TO ADVANCE THE CATHETER AND IT WOULDN'T PUSH FORWARD. IT WAS ALMOST LIKE THE END OF THE PLASTIC CATHETER WAS SPLICED OR BENT. HAD TO RESTART CATH. NO OTHER DETAILS PROVIDED. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 7/31/2025. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? HAD TO RESTART CATHETER. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NO OTHER DETAILS PROVIDED. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773219 ↗MalfunctionAug 5, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE RETRACTION PROBLEM WITH CATHETER BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IAG NOT RETRACTING PROPERLY. IT IS GETTING CAUGHT AND CAUSING CLINICIANS TO USE MULTIPLE IVS TO HAVE A SAFE RETRACTION. DESCRIBE PATIENT /(HCP) / USER IMPACT: MORE STICKS, BROKEN IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719322 ↗MalfunctionJul 28, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD INSTANCES WHERE DEVICE DID NOT RETRACT PROPERLY. ONE INCIDENT RESULTED IN A COLLEAGUE STICK.
Patient problems: Insufficient Information
MAUDE report 22637734 ↗MalfunctionJul 28, 2025Defective Device
IV CATHETER DEFECT UPON OPENING PACKAGE PRIOR TO USE ON A PATIENT. CATHETER TIP WAS PIERCED THROUGH THE SHEATH UPON OPENING PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22623095 ↗MalfunctionJun 18, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288190 ↗MalfunctionMay 15, 2025Retraction Problem; Retraction Problem
(B)(6) 2025 THERE WAS NO INJURY INVOLVED IN THE INCIDENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22024703 ↗MalfunctionMay 7, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER WOULD NOT RETRACT "OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS" (NOT DEFINED, NO RESPONSE TO QUERY).
Patient problems: Insufficient Information
MAUDE report 21981316 ↗MalfunctionApr 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: NEEDLE IS NOT RETRACTING WHEN NEEDLE IS INSERTED IN THE PATIENT. WAS PATIENT OR END-USER INJURED: NO. INJURY DETAILS: WAS MEDICAL TREATMENT REQUIRED: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858851 ↗
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-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-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-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-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-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-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-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-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 · each recall links to the FDA recall notice
- 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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