BD Insyte Autoguard 382644Recalls & reported problems

Becton, Dickinson And Company · INSYTE AUTOG BC WING GRN 18GA X 1.16IN · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This BD Insyte Autoguard winged IV catheter is a short-term intravenous line used for vascular access. Its 62 reports mostly describe needles that would not retract after insertion, sometimes with the button breaking off, plus leaking, blood leaking at the site, and a few cases where the tip sheared. No deaths or injuries were reported. There are no recalls naming this device, and reports in the last 12 months (10) are fewer than the 21 in the prior 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: 62
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00382903826445), received between Jul 31, 2018 and Mar 4, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (34 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Retraction Problem34
Leak/Splash16
Fluid/Blood Leak13
Device Contamination with Chemical or Other Material6
Break5
Defective Device2
Material Puncture/Hole2
Material Split, Cut or Torn2

Patient problems

No Clinical Signs, Symptoms or Conditions26
No Known Impact Or Consequence To Patient16
Exposure to Body Fluids12
Insufficient Information12
No Consequences Or Impact To Patient5
Hemorrhage/Blood Loss/Bleeding1
Needle Stick/Puncture1
Pain1

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 4, 2026Retraction Problem; Component Missing
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512608 ↗
MalfunctionMar 4, 2026Retraction Problem
NEEDLE WOULD NOT RETRACT AFTER IV PLACED AND BUTTON BROKE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506940 ↗
MalfunctionFeb 13, 2026Leak/Splash; Retraction Problem
NEEDLE NOT RETRACTING. THE INCIDENT HAPPENED ON (B)(6) 2026 AT 1030. THE FEATURE TO STOP THE BLEEDING BACK DID NOT WORK, CAUSING THERE TO BE A MESS FOR THE NURSE AND PATIENT, BUT DID NOT CAUSE ANY HARM. THE RN WAS ABLE TO SAFELY DISCARD OF THE NON-RETRACTED NEEDLE WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336559 ↗
MalfunctionFeb 9, 2026Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT IV CATHETER SHEARED AT THE TIP. ADDITIONAL INFORMATION RECEIVED ON 04FEB2026. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE ON PATIENT? DURING USE ON PATIENT. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290705 ↗
MalfunctionFeb 3, 2026Retraction Problem
NEEDLE WOULD NOT RETRACT AFTER IV PLACED AND BUTTON BROKE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247761 ↗
MalfunctionJan 22, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24153437 ↗
MalfunctionJan 12, 2026Material Fragmentation; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24042172 ↗
MalfunctionJan 12, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24041794 ↗
MalfunctionJan 12, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24041792 ↗
MalfunctionDec 28, 2025Leak/Splash; Material Puncture/Hole; Retraction Problem; Leak/Splash; Material Puncture/Hole; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903519 ↗
MalfunctionAug 18, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: Needle Stick/Puncture
MAUDE report 22834173 ↗
MalfunctionAug 12, 2025Break; Break
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790041 ↗
MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE BROKE (2 OF 2) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSERTION, AN INSYTE AUTOGUARD 18G IV BENT AND SUBSEQUENTLY BROKE IN HALF. IT WAS IMMEDIATELY REMOVED FROM THE PATIENT. THIS WAS THE SECOND CATHETER FROM THE SAME LOT TO EXHIBIT THE SAME ISSUE DURING THE SAME SHIFT. BOTH DEVICES WERE REMOVED PROMPTLY, THE CHARGE RN WAS NOTIFIED, AND ALL REMAINING STOCK FROM THIS LOT WAS PULLED FROM THE ED UNTIL THE MATTER CAN BE ADDRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790040 ↗
MalfunctionJul 31, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680258 ↗
MalfunctionJun 26, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER EXPERIENCING PROBLEMS VERY SIMILAR TO THE ISSUES DESCRIPED IN INSYTE AUTOGUARD RECALL. LOT IS NOT INCLUDED WITH THE RECALLED LOT NUMBERS BUT THINKING IT MAY BE THE SAME ISSUE. CUSTOMER IS SCARED TO USE THE PRODUCT WITH THE AFFECTED LOT NUMBER, AND NEEDS A FAST SOLUTION AND PRODUCT SENT OUT. ADDITIONAL INFO: COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WHEN HITTING BUTTON TO RETRACT NEEDLE IT IS GETTIGN CAUGHT IN THE IV CATHETER CAUSING IT TO PULL THE CATHETER BACK ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO TOTAL NUMBER OF OCCURRENCES? 5 TO 10 IN LOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340621 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLUGGISH WHEN RETRACTING DURING SAFETY ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047772 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLUGGISH WHEN RETRACTING DURING SAFETY ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047479 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLOW TO RETRACT ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047477 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLOW TO RETRACT WHEN SAFETY PRESSED ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047474 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLOWLY RETRACTING WHEN SAFETY PRESSED, ALLOWING BLOOD TO LEAK FROM THE HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047466 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLOW TO SAFETY WHEN BUTTON PRESSED, ALLOWING BLOOD TO LEAK BACK.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047465 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLUGGISH WHEN RETRACTING DURING SAFETY ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22047464 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLOWLY RETRACTING OR GRINDING FEELING WITH SAFETY PRESSED ALLOWING BLOOD TO LEAK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22046960 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE TRACKING VERY SLOWING WITH GRINDING FEELING ALLOWING BLOOD TO LEAK BACK FROM HUB.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22046958 ↗
MalfunctionMay 19, 2025Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKING FROM HUB WHEN SAFETY PRESSED, NEEDLE SLOW TO RETRACT.
Patient problems: Exposure to Body Fluids; Insufficient Information
MAUDE report 22046957 ↗

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-2007-2025 · May 21, 2025 · Open, Classified
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Z-2005-2025 · May 21, 2025 · Open, Classified
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Z-2000-2025 · May 21, 2025 · Open, Classified
REF: 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-2004-2025 · May 21, 2025 · Open, Classified
REF: 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, Classified
REF: 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, Classified
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Z-1999-2025 · May 21, 2025 · Open, Classified
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Z-2001-2025 · May 21, 2025 · Open, Classified
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Z-2003-2025 · May 21, 2025 · Open, Classified
REF: 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-2458-2024 · Jun 26, 2024 · Open, Classified
BD 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, Classified
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

Device details

UDI-DI	`00382903826445`
Brand	BD Insyte Autoguard
Model	382644
Company	Becton, Dickinson And Company
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K201075, K251654
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 16, 2026

Device type (GMDN): Peripheral intravenous cannula

A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

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All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

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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