BD Insyte Autoguard 381533Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN · 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 winged IV catheter is a short-term intravenous line with a retractable needle. The 34 reports mostly describe the needle being slow to retract or failing to retract at all, plus leaks at the connection, dark spots and grooves inside the tubing, and one catheter that shredded during insertion, leaving pieces in the patient's vein. There have been no deaths and 1 injury. One open recall, started in May 2025, covers the same slow or failed needle retraction.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00382903815333), received between Mar 13, 2018 and Mar 30, 2026 — classified as 1 injury, 33 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (8 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-2001-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem8
- Leak/Splash7
- Defective Component6
- Device Contamination with Chemical or Other Material3
- Material Deformation3
- Break2
- Contamination /Decontamination Problem1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- Insufficient Information2
- Foreign Body In Patient1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714025 ↗MalfunctionMar 13, 2026Product Quality Problem
IT WAS REPORTED BY CUSTOMER THAT THEY OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. INJURIES OR ADVERSE EVENT: NO. ADDITIONAL INFORMATION 3/3/2026: THE REPORT MENTIONS DARK SPOTS ON THE INNER PORTION OF THE CATHETER AND ALSO REFERS TO ROUGH SPOTS/GROOVES. DO THE ROUGH SPOTS/GROOVES REPRESENT AN ACTUAL CATHETER DEFECT, OR WERE THEY FOREIGN MATERIAL OBSERVED INSIDE THE CATHETER TUBING? THE DARK SPOTS WERE DEFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590769 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED CATHETER SHREDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: YES. SURGERY, TODAY (B)(6) 2025, HAD AN INCIDENT WITH A 20G BD INSYTE AUTOGUARD WINGED 20G X 1.00IN REF 381533, THE IV 20G 1.0 CATHETER SHEARED INTO THE PATIENT¿S VEIN WHEN THE IV ADVANCED, WHEN RETRACTED THE SHEARED PIECES CAME BACK OUT, THIS INCIDENT WAS IN THE PRE-OP ROOM.
Patient problems: Insufficient Information
MAUDE report 22811919 ↗MalfunctionApr 29, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS NOT RETRACTING WHEN ACTIVATED. INJURIES OR ADVERSE EVENT: NO. CUSTOMER RESPONSE ON (B)(6) 2025. 1. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE ON PATIENT? UNKNOWN. WAS INFORMED BY LEADERSHIP THAT THERE WAS A PROBLEM WITH THE ITEM. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. I HAVE NOT BEEN INFORMED OF ANY INJURIES TAKING PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930053 ↗MalfunctionApr 21, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN HITTING THE RETRACTION BUTTON ON THE 20G IV AFTER STARTING IV, THE NEEDLE DIDN'T RETRACT UNTIL IT WAS OUT OF CATHETER AND IT SLOWLY CONTRACTED EVEN AFTER THAT. NO HARM TO PT OR RN STARTING THE IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878017 ↗MalfunctionMar 10, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED IS UNABLE TO CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025. WE JUST ENCOUNTERED ANOTHER DEFECTIVE IV. SAME LOT NUMBER. SAME ISSUE. HISTORICAL INFORMATION: THE CATHETER HUBS HAVE EXTRA PLASTIC ON THE LUER CONNECTOR PREVENTING A WELL SEATED CONNECTION THAT LEADS TO LEAKS, REQUIRING THE STAFF TO RESTART IVS. THE PRODUCT HAS BEEN RETAINED. 13NOV IT IS MENTIONED "THERE HAVE BEEN TWO REPORTED EVENTS", WAS IT WITH DIFFERENT PATIENTS? YES CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY FOR BOTH EVENTS? 11/7/2024 AND 11/5/2024, APPARENTLY THERE WERE MORE EVENTS BEFORE THIS BUT THESE ARE THE 2 THAT I WAS MADE AWARE OF. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? AFTER; THE PROBLEM WAS NOTICED WHEN THE IV TUBING WAS UNABLE TO BE CONNECTED PROPERLY. WHAT WAS THE IMPACT TO THE PATIENT? THEY HAD TO GET STUCK AGAIN WITH A NEW IV ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. PATIENT WAS NEEDLESSLY STUCK AGAIN. NO INJURY TO THE STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21562217 ↗MalfunctionFeb 25, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21462444 ↗MalfunctionDec 26, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THAT THE IV WAS NOT WORKING, THAT THE NEEDLE WAS NOT RETRACTING. CUSTOMER TESTED A 20G AND THE NEEDLE RETRACTS SLOWLY AND EVEN NEEDED TO PRESS THE WHITE BUTTON A FEW TIMES TO HAVE IT RETRACT. THIS SLOWLY RETRACTING NEEDLE I FELT WAS NOT SAFE FOR STAFF. HER AND I NOTED THE LOT # AND WE CHECKED DIFFERENT 20 G IV¿S AND WE FOUND THAT THIS SPECIFIC LOT # WAS THE ONLY ONE THAT WAS NOT WORKING PROPERLY. AS WE WERE TALKING ABOUT THIS, DIFFERENT NURSES SAID THEY HAD THIS SAME EXPERIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21023270 ↗MalfunctionDec 8, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20874856 ↗MalfunctionNov 26, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782179 ↗MalfunctionNov 26, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781520 ↗MalfunctionSep 6, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED BLOOD LEAKS PAST BLOOD CONTROL FEATURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSING STAFF IS STATING THERE IS ISSUES WITH THE BLOOD CONTROL PORTION DESCRIBED IT AS A LOT OF BLOOD EVEN AFTER INSERTING THE IV CORRECTLY. THEY ARE ASSUMING THAT¿S THE BLOOD CONTROL PORTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161737 ↗MalfunctionJun 14, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED HUB IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VETERAN HAD AN INTRAVENOUS LINE PLACED FOR A PROCEDURE. THE HUB ON THE CATHETER WAS DEFECTIVE; WHEN AN ATTEMPT TO ATTACH THE SALINE LINE WAS MADE, THE HUB DID NOT HAVE THE REQUIRED TREAD FOR IT TO ATTACH. THIS DAMAGED EQUIPMENT RESULTED IN MULTIPLE STICKS AND DISCOMFORT FOR THE VETERAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536730 ↗MalfunctionApr 8, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19058770 ↗MalfunctionMar 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
Q: DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? A: THIS ISSUE HAPPENED DURING PATIENT USE, PATIENT WAS STUCK MULTIPLE TIMES. NO INJURY OR MEDICAL TREATMENT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891529 ↗MalfunctionFeb 6, 2024Material Deformation; Material Deformation
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18654763 ↗MalfunctionJan 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN'S ARE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOME OF THEM WILL HOLD FLOW FOR FEW SECONDS AND THEN RANDOMLY START LEAKING OUT BLOOD FROM THE TUBE. THE BATCH DOES NOT CONNECT WELL TO THE TUBING AND LEAKS A BIT DURING THE INFUSION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592779 ↗MalfunctionDec 6, 2023Material Deformation; Material Deformation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274986 ↗MalfunctionMar 23, 2023Defective Device; Defective Device
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON LOOKING AT PRODUCT THEY HAVE A BARB THAT TEARS THE VEIN WHEN STARTING IV¿S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16607641 ↗MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BROKE FROM THE HUB WHEN REMOVING THE PROTECTOR. THIS OCCURRED WITH 3 CATHETERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THAT THEY HAD 3 IV CATH COMING OFF WITH THE PROTECTOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13960943 ↗MalfunctionDec 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I WENT TO PLACE AN IV TODAY, I PULLED THE CAP OFF AND LOOKED DOWN TO CHECK THE NEEDLE/CATHETER AND THERE WAS THIS ORANGE THING ON IT. I DID NOT USE IT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13062651 ↗InjuryNov 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED A BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD THE CANNULA BREAK OFF INSIDE THE PATIENT'S VEIN, REQUIRING SURGICAL INTERVENTION.. ADDITIONALLY, ANOTHER CATHETER BROKE OFF IN THE PATIENT'S VEIN, ALSO REQUIRING SURGICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...I HAVE BEEN INJURED BY YOU GUYS TWICE I HAVE HAD TWO IVS BREAK IN MY ARM IN A SPAN OF TWO MONTHS WHICH BOTH REQUIRE SURGERY."
Patient problems: Foreign Body In Patient; Pain
MAUDE report 12849396 ↗MalfunctionJun 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN NEEDLE WENT THROUGH THE CATHETER. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE AND IT WAS THROUGH THE CATHETER, THE OUTER CATHETER OF THE IV PUNCTURED THROUGH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12095869 ↗MalfunctionMay 27, 2021Break; Break
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381533 BATCH NO.: UNKNOWN. TIP OF A INSYTE AUTOGUARD IS MALFUNCTIONING. THERE HAVE BEEN TWO RECENT DEVICES GIVEN TO ME THAT HAD ISSUES IN OUR PRE-OP DEPARTMENT. I DO NOT HAVE THE LOT NUMBER FOR THIS PARTICULAR INCIDENT. I SINCE HAVE HAD ANOTHER DEVICE GIVEN TO ME AND IT DID INCLUDE THE PACKAGE. THE LOT NUMBER FOR THIS ONE IS 0342575.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11895907 ↗MalfunctionApr 22, 2021Retraction Problem; Retraction Problem
IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN HAD A NEEDLE RETRACTION FAILURE. THIS OCCURRED ON 2 OCCASIONS.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4)BATCH NO: 0119490IT WAS REPORTED VIA MEDWATCH REPORT THAT TWO NEEDLES FAILED TO FULLY RETRACT.EVENT DESCRIPTION PER MEDWATCH REPORT STATES:TWO 20 GAUGE AUTOGUARD WINGED IVS - THE NEEDLE DID NOT COMPLETELY RETRACT ON BOTH. NO INJURY WITHI EVENT. REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11709095 ↗
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, 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-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-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-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-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-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-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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