Insyte Autoguard 381044Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 18 GA x 1.16 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD Insyte Autoguard BC Pro shielded IV catheter, a short-term intravenous line with a self-retracting needle. Reports mostly describe the needle failing to retract after use, sometimes leaving an exposed needle and blood splashing, along with leaking and occasional vessel perforation, pain, or hematoma. There are 71 reports, with no deaths and no injuries, and no recalls name this device. Reports in the last 12 months (16) are down from 35 in the prior12 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
- 70
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00382903810444), received between Dec 20, 2018 and May 18, 2026 — classified as 70 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (48 reports).
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 Problem48
- Leak/Splash17
- Defective Component4
- Device Contamination with Chemical or Other Material2
- Fluid/Blood Leak2
- Material Integrity Problem2
- Nonstandard Device2
- Activation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Insufficient Information8
- Pain3
- Perforation of Vessels3
- Hematoma2
- Anxiety1
- Needle Stick/Puncture1
- No Information1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203106 ↗MalfunctionMay 18, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203104 ↗MalfunctionMay 15, 2026Leak/Splash; Retraction Problem
IT WAS REPORTED THAT THERE WAS A NEEDLE RETRACTION ISSUE. DATE OF OCCURRENCE: 22/04/2026 IT WAS REPORTED THAT "WHEN PRESSING THE BUTTON TO CONNECT THE INFUSION LINE, THE GUIDE WIRE BECAME STUCK IN THE CATHETER CANNULA. THE NURSE GAVE A SHARP TUG, AND THE GUIDE WIRE DISENGAGED AND IMMEDIATELY RETRACTED INTO A SAFE POSITION. THERE WAS A SPLASH OF BLOOD" NO CONSEQUENCES FOR THE PATIENT. VEIN INTACT, PERFUSION PERMEABLE, NO APPARENT PAIN FOR THE PATIENT. BLOOD SPLASHED ONTO THE IADE AND THE EQUIPMENT. HAS THE PATIENT OR USER SUFFERED ANY HARM? IF SO, PLEASE EXPLAIN - NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25190364 ↗MalfunctionApr 27, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999142 ↗MalfunctionApr 7, 2026Retraction Problem
IT IS REPORTED THAT NEEDLE DOES NOT RETRACT. "SAFETY ISSUE WITH INSYTE AUTOGUARD BC PRO 18 GA × 1.16 IN CATHETERS. THE CANULA, WHICH IS NORMALLY SELF-RETRACTING, IS HAVING GREAT DIFFICULTY RETRACTING. THIS MALFUNCTION IS BECOMING INCREASINGLY DANGEROUS, AS IT ENTAILS A RISK OF AES WHEN THE CANULA IS WITHDRAWN. IT SOMETIMES CAUSES VEINS TO RUPTURE, RESULTING IN HAEMATOMAS.".
Patient problems: Hematoma; Perforation of Vessels
MAUDE report 24801788 ↗MalfunctionApr 7, 2026Retraction Problem
IT WAS REPORTED THAT INSYTE AUTOGUARD BC PRO 18 GA × 1.16 IN CATHETERS - NEEDLES DO NOT RETRACT. THE CANULA, WHICH IS NORMALLY SELF-RETRACTING, IS HAVING GREAT DIFFICULTY RETRACTING. THIS MALFUNCTION IS BECOMING INCREASINGLY DANGEROUS, AS IT ENTAILS A RISK OF AES WHEN THE CANULA IS WITHDRAWN. IT SOMETIMES CAUSES VEINS TO RUPTURE, RESULTING IN HAEMATOMAS.
Patient problems: Hematoma; Perforation of Vessels
MAUDE report 24801781 ↗MalfunctionApr 6, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. WHEN THE METAL GUIDE WIRE WAS RELEASED AFTER THE CATHETER WAS INSERTED, IT DID NOT RETRACT INTO THE CHAMBER, MEANING IT HAD TO BE REMOVED COMPLETELY FROM THE CANNULA, WITH A RISK OF ACCIDENTAL PUNCTURE. WHEN DID THE INCIDENT OCCUR? DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792444 ↗MalfunctionMar 20, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE PARTIALLY RETRACTED. UPON INSERTION, TECH WENT RETRACT STILET, WHICH WOULD NOT RETRACT. RESPONSE RECEIVED ON 3-MAR-2026: DOES THE NEEDLE FAIL TO RETRACT? YES IF YES, DOES THE NEEDLE PARTIALLY RETRACT, SLOWLY RETRACT, OR NOT RETRACT AT ALL? WE HAVE ALL 3 OCCURRENCES HAPPEN. IS THERE ANY VISIBLE CATHETER DAMAGED WHEN IT APPEARS TO BE CAUGHT ON THE NEEDLE? NOTHING VISIBLE IS THERE ANY HARM/SERIOUS INJURY TO PATIENT? NO ADDITIONAL INFORMATION RECEIVED ON 17-MAR-2026: I WAS MADE AWARE THAT TECHS HAD EXPERIENCED ALL 3 ISSUE WITH THE NEEDLE. I UNFORTUNATELY WAS AWAY FROM THE SITE WHEN THE FIRST 2 OCCURRENCES HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648606 ↗MalfunctionMar 20, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. UPON INSERTION, TECH WENT RETRACT STILET, WHICH WOULD NOT RETRACT. RESPONSE RECEIVED ON 3-MAR-2026: DOES THE NEEDLE FAIL TO RETRACT? YES IF YES, DOES THE NEEDLE PARTIALLY RETRACT, SLOWLY RETRACT, OR NOT RETRACT AT ALL? WE HAVE ALL 3 OCCURRENCES HAPPEN. IS THERE ANY VISIBLE CATHETER DAMAGED WHEN IT APPEARS TO BE CAUGHT ON THE NEEDLE? NOTHING VISIBLE IS THERE ANY HARM/SERIOUS INJURY TO PATIENT? NO. ADDITIONAL INFORMATION RECEIVED ON 17-MAR-2026: I WAS MADE AWARE THAT TECHS HAD EXPERIENCED ALL 3 ISSUE WITH THE NEEDLE. I UNFORTUNATELY WAS AWAY FROM THE SITE WHEN THE FIRST 2 OCCURRENCES HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648261 ↗MalfunctionMar 17, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618199 ↗MalfunctionMar 12, 2026Retraction Problem
TECH WENT TO INSERT IV. UPON INSERTION, TECH WENT RETRACT STILET, WHICH WOULD NOT RETRACT. ADDITIONAL INFORMATION 3 MAR 2026: COULD YOU PLEASE PROVIDE THE EXACT EVENT DATE 02/17/2026. DOES THE NEEDLE FAIL TO RETRACT? YES IF YES, DOES THE NEEDLE PARTIALLY RETRACT, SLOWLY RETRACT, OR NOT RETRACT AT ALL? WE HAVE ALL 3 OCCURRENCES HAPPEN. IS THERE ANY VISIBLE CATHETER DAMAGED WHEN IT APPEARS TO BE CAUGHT ON THE NEEDLE? NOTHING VISIBLE. IS THERE ANY HARM/SERIOUS INJURY TO PATIENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579561 ↗MalfunctionMar 12, 2026Retraction Problem
TECH WENT TO INSERT IV. UPON INSERTION, TECH WENT RETRACT STILET, WHICH WOULD NOT RETRACT. ADDITIONAL INFORMATION 3 MAR 2026: COULD YOU PLEASE PROVIDE THE EXACT EVENT DATE (B)(6) 2026. DOES THE NEEDLE FAIL TO RETRACT? YES. IF YES, DOES THE NEEDLE PARTIALLY RETRACT, SLOWLY RETRACT, OR NOT RETRACT AT ALL? WE HAVE ALL 3 OCCURRENCES HAPPEN. IS THERE ANY VISIBLE CATHETER DAMAGED WHEN IT APPEARS TO BE CAUGHT ON THE NEEDLE? NOTHING VISIBLE. IS THERE ANY HARM/SERIOUS INJURY TO PATIENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579559 ↗MalfunctionMar 11, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571383 ↗MalfunctionFeb 20, 2026Leak/Splash; Retraction Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24401059 ↗MalfunctionFeb 20, 2026Leak/Splash
MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23386587 ↗MalfunctionOct 23, 2025Nonstandard Device; Retraction Problem; Defective Component; Nonstandard Device; Retraction Problem; Defective Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372779 ↗MalfunctionOct 23, 2025Nonstandard Device; Retraction Problem; Defective Component; Nonstandard Device; Retraction Problem; Defective Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372777 ↗MalfunctionOct 21, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23344566 ↗MalfunctionOct 16, 2025Retraction Problem; Retraction Problem
A MALFUNCTION OF THE CATHETER SAFETY SYSTEM WAS OBSERVED. WHEN THE BUTTON FOR REMOVING THE CANULA WAS PRESSED, THE CANULA BECAME STUCK IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316753 ↗MalfunctionSep 12, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039692 ↗MalfunctionSep 12, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039625 ↗MalfunctionSep 5, 2025Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem
DATE OF OCCURRENCE: (B)(6) 2025 CIRCUMSTANCES SURROUNDING THE INCIDENT / DESCRIPTION OF EVENTS: DURING INSERTION OF A PERIPHERAL VENOUS CATHETER, THE NEEDLE FAILED TO RETRACT WHEN THE SAFETY SYSTEM WAS TRIGGERED. THE SPRING SYSTEM, WHICH SHOULD NORMALLY RETRACT WITH THE PUNCTURE NEEDLE, SEPARATED FROM THE NEEDLE AND ENDED UP AT THE BOTTOM OF THE HANDLE, WITHOUT RELEASING THE ANTI-REFLUX VALVE. THIS CAUSED A JET OF BLEEDING AT THE BOTTOM OF THE PERFORATED HANDLE, RESULTING IN A MASSIVE SPREAD OF BLOOD OVER THE PATIENT'S ENVIRONMENT AND THE MIDWIFE'S OUTFIT. CLINICAL CONSEQUENCES OBSERVED: - RISK OF BLOOD EXPOSURE. - RISK OF INJURY DUE TO FAILURE TO RETRACT THE PUNCTURE NEEDLE. - SPOLIATION OF PATIENT'S BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984048 ↗MalfunctionAug 28, 2025Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN INSERTING A 18G RETRACTABLE PERIPHERAL VENOUS CATHETER, BATCH: 4361603, THE CANULA DID NOT RETRACT PROPERLY AND APPEARED TO BE BLOCKED. THE ANTI-REFLUX FUNCTION OF THE CATHETER WAS BLOCKED, CAUSING SIGNIFICANT BLOOD FLOW. AFTER SLIGHT MANIPULATION, THE NEEDLE RETRACTED COMPLETELY AND THE ANTI-REFLUX FUNCTION WAS RESTORED." THE MEDICAL DEVICE IN QUESTION WAS NOT KEPT BY THE DEPARTMENT. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT AND THE PROCEDURE WAS NOT PROLONGED. HOWEVER, THE RISK WAS TO THE PROFESSIONAL, AS THE ACTION CREATED A RISK OF A SERIOUS ADVERSE EVENT. THE PROFESSIONAL WAS PROTECTED, WHICH MEANT THAT THERE WERE NO PROVEN CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916723 ↗MalfunctionAug 20, 2025Retraction Problem; Retraction Problem
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: CATHETER WING ONLY PARTIALLY RETRACTS. THE CANULA ON THE 18G CATHETER ONLY PARTIALLY RETRACTED, RESULTING IN A HIGH RISK OF BSE (BLOOD EXPOSURE ACCIDENT) FOR THE NURSE AND BLEEDING BY THE PATIENT. ACCORDING TO THE NURSE, THIS HAS ALREADY HAPPENED WITH 18GR CATHETERS (BATCH NUMBER UNKNOWN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22851922 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
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- 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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