BD Insyte Autoguard 381512Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD WINGED YEL 24GA X .75IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard winged IV catheter is a short-term IV catheter. The 74 reports mostly describe leaking or splashing at the insertion site, contamination or dark spots and grooves inside the catheter, plastic splitting or cracking during needle insertion, and retraction problems. There are no deaths and 1 injury. No recalls name this device. Reports increased from 3 in the prior 12 months to 12 in the last 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
- 73
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00382903815128), received between Oct 17, 2017 and May 27, 2026 — classified as 1 injury, 72 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (32 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
Most reported problems
Device problems
- Leak/Splash32
- Device Contamination with Chemical or Other Material17
- Material Split, Cut or Torn9
- Retraction Problem8
- Break4
- Defective Component3
- Fluid/Blood Leak3
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient13
- Insufficient Information8
- Needle Stick/Puncture2
- Pain2
- Discomfort1
- Extravasation1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. THE PLASTIC CATHETER SPLIT IN HALF WHILE INSERTING THE NEEDLE. THIS HAS HAPPENED A FEW TIMES OVER THE LAST WEEK. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304328 ↗MalfunctionMay 20, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. THE PLASTIC CATHETER SPLIT IN HALF WHILE INSERTING THE NEEDLE. THIS HAS HAPPENED A FEW TIMES OVER THE LAST WEEK. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233387 ↗MalfunctionMar 30, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOREIGN MATTER WAS NOTED ON A CATHETER. REPORTED ISSUE: OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714584 ↗MalfunctionMar 30, 2026Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713968 ↗MalfunctionMar 23, 2026Retraction Problem
MalfunctionMar 23, 2026Connection Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. WE'VE EXPERIENCED HAVE BEEN SPLITTING OF THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 24662048 ↗MalfunctionMar 23, 2026Retraction Problem
MalfunctionMar 20, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. THERE WAS ALSO A RECENT INCIDENT WHERE AN IV WAS PLACED WITH A SPLIT IN IT; FORTUNATELY, IT DID NOT BREAK OFF INTO THE PATIENT. THE NURSE FELT SOMETHING WAS OFF WHILE THREADING IT AND NOTICED THE SPLIT BEFORE ADMINISTERING ANYTHING AND PULLED IT OUT RIGHT AWAY. ADDITIONAL INFORMATION 3/11/2026: ONE EVENT DID REACH THE PATIENT AND THE PATIENT COMPLAINED OF PAIN AT INSERTION SITE. NEGATIVE OUTCOMES: WASTED PRODUCT, STAFF NOT TRUSTING THAT A 24 G WILL WORK PROPERLY. ADDITIONAL INFORMATION 3/17/2026: DUE TO REGULATORY REPORTING REQUIREMENTS, PLEASE PROVIDE WHICH REPORTED EVENT DATE AND LOT NUMBER IS ASSOCIATED WITH THE ONE EVENT THAT OCCURRED/WAS NOTICED DURING THE IV INSERTION PROCESS. EVENT DATE WAS 2/24/26. INSYTE AUTOGUARD WINGED YEL 24GA X .75IN 381512, LOT 5267948.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24652882 ↗MalfunctionMar 19, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. I HAD AN ISSUE WITH THE AUTOMATIC PUSH-BUTTON NEEDLE RETRACTION SAFETY MECHANISM AT WORK TODAY. THE NEEDLE DID NOT RETRACT INTO THE PROTECTIVE CHAMBER WHEN THE SAFETY BUTTON WAS DEPRESSED. ADDITIONAL INFORMATION 3/13/2026: THE ISSUE HAPPENED WHEN I WAS VISITING THE PATIENT'S HOME AND USING THE PRODUCT TO START AN IV. SUPPLIES SHIPPED BY ACCREDO. NO INJURY TO ME, BUT I DID END UP HAVING TO RESTART THE IV ON THE PATIENT (EXTRA NEEDLE STICK) DATE OF EVENT: 11-03-2026 THE NEEDLE DID NOT RETRACT AT ALL WHEN THE WHITE BUTTON WAS PRESSED. THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640657 ↗MalfunctionFeb 6, 2026Product Quality Problem
INSERTING 24G BD INSYTE IV CATHETER WITH LOT NUMBER 5267948 FOR INFUSION. CATHETER APPEARED WNL PRIOR TO INSERTION. UPON INSERTION AND BLOOD FLASH ATTEMPTED TO ADVANCE CATHETER OFF OF NEEDLE AND FELT IT "CATCH" AFTER PARTIAL ADVANCEMENT. PATIENT REPORTED INCREASED DISCOMFORT WITH THAT. GIVEN THE UNEXPECTED FEEL OF ADVANCING AND PATIENTS REPORT OF INCREASE DISCOMFORT. DECISION MADE TO WITHDRAW NEEDLE AND CATHETER AND START OVER. UPON REMOVING NEEDLE & CATHETER THE CATHETER WAS NOTED TO HAVE A PLASTIC" SPUR STICKING OUT OF THE SIDE APPROX 1/3 UP THE CATHETER. ALL PIECES OF PLASTIC APPEARED TO BE PRESENT AND NO PIECES WERE NOTED TO BE MISSING. SECOND IV ATTEMPT MADE WITH IV FROM RN STOCK WITH DIFFERENT LOT NUMBER WAS SUCCESSFUL AND PROCEEDED AS EXPECTED.
Patient problems: Discomfort
MAUDE report 24279942 ↗MalfunctionJan 28, 2026Retraction Problem
MalfunctionJul 11, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22479674 ↗MalfunctionApr 2, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758798 ↗MalfunctionApr 1, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21741453 ↗MalfunctionOct 24, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION OF THE CATHETER AND WHILE ATTEMPTING TO THREAD THE NEUTRAL CONNECTOR, OR CAP, ONTO THE CATHETER, I NOTICED THAT THE CAP WOULD NOT SLIDE INTO THE GROOVE OF THE IV CATHETER. AFTER REMOVING THE IV CATHETER FROM THE PATIENT, I NOTICED THE EDGE OF THE CATHETER HAD AN EXTRA HIGH EDGE. 8 OCT TO ANSWER YOUR QUESTIONS THERE WAS NOT ANY INJURY TO REPORT AND THERE WASN'T A SERIOUS INJURY TO THE PATIENT. THIS OCCURRED TO ME WITH ONE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20529164 ↗MalfunctionSep 6, 2024Material Perforation; Material Perforation
MalfunctionMar 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18972039 ↗MalfunctionMar 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BD NSYTE AUTOGUARD WINGED CATHETER TIP INTEGRITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH THE NEW SUBS FOR THE IV CATHETERS LYN HAS HAD THE NEEDLE GO THROUGH THE SMALL SHEATH ON TWO DIFFERENT DEVICES. IT MAY HAVE BEEN CRACKED AS SHE DID NOT PULL THE NEEDLE BACK AND REINSERT. NOT SURE IF THIS HAS BEEN REPORTED FROM ANY OTHER AREAS BUT WE WANTED TO GET THAT TO SUPPLY CHAIN TO MAKE SURE IT WAS RECOGNIZED. I TALKED TO AMBER SHE SAID THE CATHETER SHEARED ON TWO SEPARATE IV'S WITH THE SAME RN HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? BOTH PATIENTS NEEDED SECOND ATTEMPT AT IV. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18972036 ↗MalfunctionDec 21, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED SHEARS DURING ATTEMPTS TO THREAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED BY THE ACCOUNT "I HAVE A BATCH OF 24GX0.75 IV CATHS THAT ARE MALFUNCTIONING WHEN THREADING, THEY SEEM TO BE STICKING AND EITHER KINKING OR SHREDDING WHEN THREADING. LOT NUMBER 3096295 THIS HAS HAPPENED SEVERAL TIMES. I USED ULTRASOUND YESTERDAY TO ENSURE I WAS IN THE VEIN , GREAT BLOOD RETURN AND WHEN I ADVANCED TO THREAD IT KINKED ON THE NEEDLE AND WOULD NOT ADVANCE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371022 ↗MalfunctionOct 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS SPLITTING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: BD INSYTE AUTOGUARD WINGED 24 GAUGE CATHETER SPLIT PRIOR TO NEEDLE INSERTION.
Patient problems: Insufficient Information
MAUDE report 17852433 ↗MalfunctionOct 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED WHILE USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IT SPLIT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: BD INSYTE AUTOGUARD CATHETER 24 GAUGE WINGED LOT NUMBER 3055427 CATHETER SPLIT, NEEDLE PUNCTURED THROUGH THE SIDE OF THE CATHETER. IDENTIFIED AS A TREND WITH THIS PRODUCT.
Patient problems: Insufficient Information
MAUDE report 17852431 ↗MalfunctionSep 28, 2023Material Protrusion/Extrusion; Material Split, Cut or Torn; Material Protrusion/Extrusion; Material Split, Cut or Torn
IT WAS REPORTED THAT THE NEEDLE SPLIT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD WINGED 24 GAUGE IV CATHETER LOT # 3096295 REF (B)(4) NEEDLE SPLIT THE CATHETER SHEATH. TREND HAS BEEN IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 17839790 ↗MalfunctionSep 28, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AFTER INSERTING THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD INSYTE AUTOGUARD WINGED 24 GAUGE CATHETER LOT # 3129607 NEEDLE SPLIT THROUGH CATHETER SHEATH. THIS WAS NOTED AFTER IV INSERTED AND UNABLE TO ADVANCE. RN REMOVED NEEDLE/CATHETER. TREND HAS BEEN IDENTIFIED WITH THIS PRODUCT, MULTIPLE LOT NUMBERS IMPACTED."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17837308 ↗MalfunctionSep 12, 2023Crack; Obstruction of Flow; Crack; Obstruction of Flow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17730315 ↗MalfunctionApr 8, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED (SHORT DESCRIPTION OF EVENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST RECENTLY HAD THE SAME NURSE WHO REPORTED THIS COMPLAINT REPORT THAT THE SAME EXACT INCIDENT HAPPENED WITH ANOTHER IV CATHETER WITH THE SAME LOT NUMBER DURING ANOTHER INFUSION. IT WAS REPORTED BY THE CUSTOMER THAT THE NURSE TRIED TO ATTACH THE EXTENSION TUBING TO THE IV CATHETER THERE WAS LEAKING AROUND THE POINT WHERE THE CATHETER AND TUBING CONNECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16705182 ↗
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-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-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-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-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-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-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
- 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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