BD Insyte Autoguard 382633Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC WING 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 IV catheter has 129 adverse event reports on record, with no deaths and 1 injury. The reports mostly describe the safety needle failing to retract or retracting slowly, and some mention leaks, air being drawn in, or catheter tips breaking. There is 1 open recall, started in May 2025, because the needle may be slow to retract or fail to retract. The last 12 months show 10 reports, compared with 71 in the 12 months before.
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
- 126
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00382903826339), received between Mar 15, 2018 and Jun 26, 2026 — classified as 1 injury, 125 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (80 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-2000-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem80
- Leak/Splash8
- Break6
- Defective Component6
- Material Split, Cut or Torn6
- Device Markings/Labelling Problem5
- Device Contamination with Chemical or Other Material4
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Insufficient Information12
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- No Patient Involvement3
- Easy Bruising2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Air/Gas in Device
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING DREW AIR DURING ASPIRATION. WE HAD MULTIPLE INCIDENTS WITH THE 20G IV CATHETERS WHERE WE WILL PLACE THE IV, BUT AS WE ARE TRYING TO DRAW BLOOD INTO A SYRINGE OR J LOOP, IT PULLS MOSTLY AIR. THE HUBS OF THE IV CATHETERS DO NOT LOOK CRACKED. POSSIBLY THE SEAL BETWEEN THE CATHETERS AND THE HUBS ARE COMPROMISED. NO PATIENT IMPACT/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637154 ↗MalfunctionMay 20, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. WE HAVE IDENTIFIED AT LEAST ONE INCIDENT WHERE AN IV NEEDLE THAT MALFUNCTIONED ADDITIONAL INFORMATION RECEIVED ON 06MAY2026: PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? (B)(6) 2026. PLEASE PROVIDE A DETAILED DESCRIPTION OF THE ISSUE ENCOUNTERED WITH THE NEEDLE MALFUNCTION. THE NEEDLE DID NOT RETRACT AFTER THE NURSE HAD STARTED THE IV AND PRESSED THE WHITE BUTTON TO RETRACT IT. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233904 ↗MalfunctionMar 12, 2026Retraction Problem
MalfunctionFeb 17, 2026Material Split, Cut or Torn
CATHETER SHEARED AT TIP I DON¿T HAVE ANY INFORMATION REGARDING THE PATIENTS THEMSELVES. 2/9/26 DID THE REPORTED CATHETER TIP SHEARING OCCUR DURING THE IV INSERTION ATTEMPT OR WAS IT DISCOVERED WHEN OPENING THE POUCH? DURING (B)(6) 2026 DURING IV INSERTION ATTEMPT.
Patient problems: Insufficient Information
MAUDE report 24369395 ↗MalfunctionFeb 13, 2026Retraction Problem
MalfunctionDec 5, 2025Break; Leak/Splash; Break; Leak/Splash
MalfunctionNov 12, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
(B)(6) 2025. NO REPORTED INJURIES SO FAR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23536763 ↗MalfunctionSep 11, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030488 ↗MalfunctionAug 8, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WERE CONDUCTING DV TESTING AT BDTI USING THE 20 GA X 1.00 INCH IAG BC WINGED PRODUCT, (SKU 382633, LOT 5149270) AND THE NEEDLE OF ONE OF OUR SAMPLES DID NOT RETRACT WHEN THE BUTTON WAS PRESSED. CONTINUED BUTTON PRESSING DID NOT CAUSE THE NEEDLE TO RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22753885 ↗MalfunctionJul 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CITES BD RECALL DOCUMENT. ADDITIONAL INFORMATION RECEIVED ON 17JUL2025: THANK YOU FOR REACHING OUT. YES, I AM CONFIRMING WE HAVE EXPERIENCED THE RETRACTION ISSUE OF THIS ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22568620 ↗MalfunctionMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING LEAKED BEYOND THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WOULD NOT RETAIN BLOOD.UNFORTUNATELY, THE ONLY INFORMATION I HAVE IS WHAT IS NOTED ON THE DOCUMENT I SENT. I CAN TELL YOU THERE WE NO INJURIES REPORTED FOR ANY OF THESE DEFECTIVE RETURNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21990783 ↗MalfunctionMar 24, 2025Crack; Leak/Splash; Crack; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21683909 ↗MalfunctionMar 24, 2025
WHEN INSERTING THE IV CATHETER THE BLOOD BACK FLOWED THROUGH THE STAT LOC AND INTO THE IV LINE. LOT # 4352441 BD INSYTE AUTOGUARD BC WINGED 20GA X 1 IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676142 ↗MalfunctionMar 24, 2025
THE IV CATHETER DID NOT GIVE ANY FLASH WHEN INSERTING THE IV UNTIL WE WENT TO TAKE OUT THE IV AND AT THAT POINT, WE COULD NOT SAVE THE VEIN AS IT WAS ALMOST OUT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extravasation
MAUDE report 21676141 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
MalfunctionFeb 4, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE IS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE IVS WOULD NOT DEPLOY AND THE OTHER HAD A DEFECTIVE SAFETY MECHANISM. THEY HAVE SEEN SEVERAL OF THESE INCIDENTS WITH THE TWO LOTS NOTED. THE NURSE SUPERVISOR INFORMED ME THAT THE ED NURSES WERE HAVING TROUBLE WITH THESE 20GA. IV CATHETERS. WHEN THEY PUSH THE WHITE BUTTON ON THE CATHETER IT IS HAVING A SLOW DELAY ON RETRACTING. WHEN NORMALLY IT RETRACTS QUICKLY. NO INJURY REPORTED, ONLY MULTIPLE STICK REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309563 ↗MalfunctionJan 29, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE RETRACTION IS SLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT WHEN USING ITEM 382633, LOT 4222721, THERE IS A DELAY WHEN PUSHING THE BUTTON AND THE NEEDLE DOES NOT RETRACT. DATE OF EVENT: 13JAN2025; OCCURRENCE NUMBER: 3. CUSTOMER DOES HAVE PRODUCT TO RETURN IF NEEDED. ADDRESS OF FACILITY: (B)(6) 2025 THE NEEDLES HAD A DELAYED RETRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21269960 ↗MalfunctionJan 28, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 GAUGE NEEDLES - NURSES HAVE NOTICED DIFFICULTY IN THE NEEDLES NOT RETRACTING BACK IN ONCE THEY HAVE BEEN USED. WHEN THEY PUSH THE BUTTON TO RETRACK THE NEEDLE, THE NEEDLE GETS STUCK AND THEY HAVE TO USE THEIR FINGER TO ASSIT IT TO RETRACT. EVEN THOUGH THEY PUSH THE BUTTON MULTIPLE TIMES IT DOES NOT RETRACT. HOWEVER WHEN THEY TESTED A NEEDLE THAT HAS NOT BEEN USED ON A PATIENT, THE NEEDLE RETRACTS AS DESINGED. THIS ISSUE MAY BE RELATED TO THE LOT, BUT IT ONLY OCCURS WHEN USED ON A PATIENT. THEY HAVE SAID THEY DO NOT HAVE ISSUES ON THE 22 GAUGE NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21254184 ↗MalfunctionJan 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I'M REACHING OUT TO REPORT A MALFUNCTION WITH A DEVICE WE HAVE AT OUR FACILITY. IT IS THE BD INSYTE AUTO GUARD 20 G X 1.00 IN. THE NEEDLE IS SLOW TO RETRACT OR WILL NOT RETRACT COMPLETELY LEAVING THE NEEDLE EXPOSED FOR A POTENTIAL NEEDLESTICK. I WILL ATTACH THE PICTURE THAT HAS THE IDENTIFIERS ON IT. THEY HAVE SEEMED TO BE CONTAINED TO THE SAME LOT RIGHT NOW. THE LOT #4222721. ITEM ¿ 382633. CUSTOMER RESPONSE OCTOBER 31, 2024: 1) NO IMPACT TO PATIENT. 2) NO SERIOUS INJURY TO HCP. 3) (B)(6) 2024. 4) NO SAMPLES, JUST THE LOT NUMBER THAT WAS INVOLVED THAT I SENT IN THE INITIAL INFORMATION. 5) NO MEDICATIONS GIVEN IN THE START OF THE IV. 6) YES, BUTTON WAS DEPRESSED. THE BUTTON APPEARED TO GET STUCK AND LEAVE A PORTION OF THE NEEDLE EXPOSED. 7) THE NEEDLE DID RETRACT, NOT FULLY. NO NEEDLE STICK INJURIES REPORTED. CUSTOMER RESPONSE: NOV 6, 2024. 6. (2) APPROXIMATELY 15 OR MORE TIMES. 6. (3) (B)(6) 2024. #7 ANSWERS ARE THE SAME AS ABOVE. CUSTOMER RESPONSE ON JAN 06, 2025. WE NEED SOME ADDITIONAL CLARIFICATION REGARDING THE DATES PROVIDED IN THE PREVIOUS RESPONSES: (B)(6) 2024, (B)(6) 2024. COULD YOU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179336 ↗MalfunctionJan 16, 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: WHEN PLACING THE IV AND TRYING TO RETRACT THE NEEDLE WITH THE AUTO BUTTON, THE BUTTON DID NOT DEPRESS AND RETRACT THE NEEDLE. THE BUTTON FELT AS THOUGH IT WAS STICKING.
Patient problems: Insufficient Information
MAUDE report 21175369 ↗MalfunctionDec 30, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, I¿M A PARAMEDIC ON THE ACCESS TEAM AT (B)(6). I MORE JUST WANT TO BRING AN ISSUE MY TEAM HAS BEEN HAVING FOR THE PAST 6-8 MONTHS WITH THESE IV CATHETERS SO YOU ARE AWARE. I¿VE BEEN USING THESE NEEDLES FOR THE PAST 5 YEARS WITH NO ISSUES AT ALL. BUT 6-8 MONTHS AGO ME AND MY TEAM NOTICED THAT UPON CLICKING BUTTON TO RETRACT NEEDLE IT HAS BEEN GETTING CAUGHT INSIDE CATHETER AT HALF WAY. TO RELEASE IT WE HAVE NEEDED TO EITHER WAIT A FEW SECONDS OR WIGGLE IT. I FELT THAT I SHOULD AT LEAST PUT IT ON YOUR RADAR IF IT¿S NOT ALREADY AS VERY RECENTLY THIS ISSUE HAS CAUSED CATHETERS TO ALMOST BE COMPLETELY PULLED OUT. ME AND ANOTHER MEMBER OF OUR TEAM HAS HAD A FEW INSTANCES WHERE WE CLICKED THE BUTTON TO RETRACT NEEDLE AND WHILE RETRACTING IT GOT STUCK MIDWAY IN CATHETER BUT PULLED THE CATHETER OUT WITH IT. SO FAR WE HAVE BEEN ABLE TO RECOVER THE LINE EASILY BUT I¿M SURE YOU GUYS DON¿T INTEND FOR THE NEEDLES TO GET CAUGHT AND IT HAS BECOME A REGULAR OCCURRENCE OVER MONTHS ACROSS MULTIPLE DIFFERENT SETS OF NEEDLES. WE HAVE MOSTLY NOTICED IT WITH 20GS AS THAT¿S THE SIZE WE USE MOST. (B)(6) 2024 THIS IS
Patient problems: Insufficient Information
MAUDE report 21044829 ↗MalfunctionDec 30, 2024Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21044738 ↗MalfunctionDec 30, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY FEATURE IS NOT ACTIVATING. THE BUTTON WON¿T RETRACT THE NEEDLE. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21041543 ↗MalfunctionDec 26, 2024Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020448 ↗MalfunctionDec 12, 2024Retraction Problem; Retraction Problem
MATERIAL #:382633. BATCH#:4222721. IT WAS REPORTED BY CUSTOMER THAT THE INSYTE AUTOGUARD IV CATHETERS HAVE BEEN RESISTANT TO RETRACTING USING THE PUSH BUTTON TECHNIQUE DESIGNED. THIS HAS OCCURRED A MINIMUM OF 9 TIMES TO THE SUPERVISOR'S KNOWLEDGE. NO EMPLOYEE OR PATIENT INJURY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20912670 ↗
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-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-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-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-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-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-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-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-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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