Insyte AutoguardRecalls & reported problems across all models
Becton, Dickinson And Company · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Insyte Autoguard model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 516
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 2
We found 20 models of Insyte Autoguard by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 516 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2018 and Sep 30, 2026 — classified as 34 injuries, 482 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (190 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Insyte Autoguard recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2025Open, Classified
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2006-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
- May 21, 2025Open, Classified
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2003-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported Insyte Autoguard problems
Device problems
- Retraction Problem190
- Leak/Splash95
- Defective Component34
- Contamination24
- Break23
- Device Contamination with Chemical or Other Material22
- Fluid/Blood Leak21
- Packaging Problem19
Patient problems
- No Clinical Signs, Symptoms or Conditions410
- Insufficient Information33
- No Known Impact Or Consequence To Patient26
- Foreign Body In Patient16
- Pain15
- Needle Stick/Puncture8
- Perforation of Vessels8
- Extravasation6
Insyte Autoguard models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Insyte Autoguard 381023Catheter, intravascular, therapeutic, short-term less than 30 days173 reports
- Insyte Autoguard 381923Catheter, intravascular, therapeutic, short-term less than 30 days1 recall25 reports
- Insyte Autoguard 381012Catheter, intravascular, therapeutic, short-term less than 30 days71 reports
- Insyte Autoguard 381044Catheter, intravascular, therapeutic, short-term less than 30 days70 reports
- Insyte Autoguard 382944Catheter, intravascular, therapeutic, short-term less than 30 days1 recall11 reports
- Insyte Autoguard 381034Catheter, intravascular, therapeutic, short-term less than 30 days46 reports
- Insyte Autoguard 381912Catheter, intravascular, therapeutic, short-term less than 30 days35 reports
- Insyte Autoguard 381033Catheter, intravascular, therapeutic, short-term less than 30 days27 reports
- Insyte Autoguard 382923Catheter, intravascular, therapeutic, short-term less than 30 days16 reports
- Insyte Autoguard 381833Catheter, intravascular, therapeutic, short-term less than 30 days13 reports
- Insyte Autoguard 382933Catheter, intravascular, therapeutic, short-term less than 30 days11 reports
- Insyte Autoguard 382934Catheter, intravascular, therapeutic, short-term less than 30 days5 reports
- Insyte Autoguard 381934Catheter, intravascular, therapeutic, short-term less than 30 days3 reports
- Insyte Autoguard 381944Catheter, intravascular, therapeutic, short-term less than 30 days3 reports
- Insyte Autoguard 381837Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- Insyte Autoguard 381847Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- Insyte Autoguard 381867Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- Insyte Autoguard 381933Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- Insyte Autoguard 382912Introducer, catheter1 report
- Insyte Autoguard 382957Catheter, intravascular, therapeutic, short-term less than 30 days1 report
Recent Insyte Autoguard adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
It was reported that BD INSYTE AUTOG BC GLOBAL leaked beyond the blood control feature.Reported blood splatter from the rear end of the safety barrel during blood collectionDetailed Safety Issue: Risk of Infection from Blood Splatter
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946181 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was determined through the investigation that BD INSYTE AUTOG BC GLOBAL needle was damaged or defective. Customer report: t was reported that "The tip of the catheter needle became deformed during the patient's infusion"Actions taken at the healthcare facility to manage the patient: The faulty device was removed. Another device was used.Response Received on:7/27/2026When was the defect identified? During or after use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933033 ↗MalfunctionJul 2, 2026Material Puncture/Hole
IT WAS DETERMINED THAT BD INSYTE AUTOG BC GLOBAL NON FOREIGN MATTER WAS FOUND DURING INVESTIGATION. ORIGINAL REPORT: "IT WAS REPORTED THAT THE NEEDLE HAD POPPED OUT OF THE CATHETER BEFORE USE." "SALES REP MENTIONED THAT: WHEN THEY OPENED THE PACKAGE, THE NEEDLE WAS STICKING OUT OF THE CATHETER. THEY HAVE REPORTED THIS SAME ISSUE NUMEROUS TIMES IN THE PAST. NATURALLY, THEY DID NOT PERFORM THE PUNCTURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25689283 ↗MalfunctionJun 23, 2026
WHEN INSERTING THE IV, THE TIP OF THE IV WENT IN, BUT UNABLE TO ADVANCE FURTHER. 2ND IV ATTEMPTED WITH DIFFERENT LOT NUMBER WITHOUT DIFFICULTY AND IV WAS SUCCESSFULLY PLACED. OTHER STAFF REPORTED SEVERAL INSTANCES OF SAME ISSUE WITH IV CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592458 ↗InjuryJun 18, 2026Break
I WOULD LIKE TO REPORT AN PRODUCT INCIDENT WITH BD INSYTE AUTOGUARD CANNULA 20G (PINK) ON (B)(6) 2026 INVOLVING THE CANULA LINE BREAKING APART AND PART BEING LEFT INSIDE A PATIENT AT (B)(6) HOSPITAL. THE PATIENT HAD TO GO TO THEATRE TO HAVE THE PART REMAINING INSIDE THEM REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 25550007 ↗MalfunctionJun 16, 2026Retraction Problem
ACCORDING TO THE CUSTOMER REPORT, THERE WAS NO MOVEMENT OF THE NEEDLE WHEN THE BUTTON WAS PRESSED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526677 ↗MalfunctionJun 11, 2026Retraction Problem
THE CUSTOMER COMPLAINED THAT THE NEEDLE COULD NOT BE FULLY RETRACTED AFTER USE.WAS THERE ANY IMPACT TO A PATIENT, HCP, USER OR OTHER? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474086 ↗MalfunctionJun 8, 2026
RN WENT TO START PIV WITH 22G PIV NEEDLE/CATHETER, THE NEEDLE BARELY PENETRATED THE SKIN AND THE CATHETER WOULD NOT GO INTO THE SKIN. THIS RN RETRACTED THE NEEDLE TO DISCOVER THE CATHETER WAS FRAYED AND SQUARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425926 ↗MalfunctionJun 8, 2026
RN ATTEMPTED PIV [PERIPHERAL IV] INSERTION; CATHETER FRAYED DURING INSERTION. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425925 ↗MalfunctionJun 8, 2026
PRODUCT "SHEARED" IN PATIENT'S SKIN DURING THE IV INSERTION. CATHETER WAS REMOVED FROM PATIENT FULLY INTACT.
Patient problems: Foreign Body In Patient
MAUDE report 25425878 ↗MalfunctionJun 3, 2026Retraction Problem
IT WAS REPORTED THAT THE SAFETY DEVICE DID NOT WORK DURING USE. NEEDLE STICK MECHANISM NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382735 ↗MalfunctionJun 1, 2026Material Puncture/Hole
IT WAS REPORTED THAT CUSTOMER PUNCTURED THE CATHETER AND FED IT, BUT WHEN THEY LOOKED AT THE CATHETER, THEY THOUGHT IT WASN'T GOING VERY FAR, SO THEY LOOKED AT THE CATHETER AND SAW THAT IT WAS STICKING THROUGH DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351469 ↗MalfunctionMay 29, 2026Mechanical Problem
IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE ROLLER CLAMP ON THE IV ADMINISTRATION SET IS DIFFICULT TO ADJUST DRIP RATE, AND IT IS LEAVING MARKS ON THE IV TUBING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326816 ↗InjuryMay 27, 2026Break
IT WAS REPORTED THAT CATHETER BROKE/SEPARATED. IT WAS REPORTED THAT SVH HAVE HAD TO SURGICALLY REMOVE THE CANNULA OF THIS PRODUCT AFTER IT WAS RETAINED. I AM STILL WORKING THROUGH THE EVENTS LEADING UP TO THIS HOWEVER IT'S BELIEVED IT HAS BEEN RETAINED FOR ABOUT 5 WEEKS WHICH MAKES IT DIFFICULT TO ASCERTAIN THE LOT NUMBER. 14-MAY-2026 PLEASE CONFIRM THAT THE CATHETER BROKE OFF AND REMAINED IN THE PATIENT. YES. WHERE ON THE CATHETER TUBING DID THE CATHETER BREAK? DID THE CATHETER SEPARATE FROM THE ADAPTER, OR DID IT BREAK OFF SOMEWHERE ALONG THE CATHETER TUBING LENGTH? BY MEASURING IT AGAINST AN INTACT CATHETER IT APPEARS THAT IT BROKE AT THE WELD WITH THE HUB. WHAT WAS THE CATHETER BEING USED FOR AT THE TIME OF THE FAILURE? IVF WAS A POWER INJECTOR BEING USED? I WILL DOUBLE-CHECK THIS HOWEVER DO NOT BELIEVE SO AS THE PATIENT WAS A SURGICAL PATIENT UNDER ONCOLOGY.
Patient problems: Foreign Body In Patient
MAUDE report 25302625 ↗MalfunctionMay 27, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. "DESCRIBE CUSTOMER CONCERN, DETAILS OF EVENT INCLUDING HOW THE ISSUE WAS RESOLVED THE HEAD NURSE FROM THE ONCOLOGY CENTER AT NKTI EXPERIENCED A DELAY IN NEEDLE RETRACTION WHILE USING THE INSYTE AUTOGUARD G24 FOR A PATIENT UNDERGOING CHEMOTHERAPY INFUSION. INITIALLY, SHE BELIEVED THE ISSUE WAS ISOLATED TO A SINGLE DEVICE. HOWEVER, UPON REPEATED USE OF DEVICES FROM THE SAME BATCH AND LOT NUMBER, SHE CONSISTENTLY OBSERVED THE SAME DELAY. AFTER INSERTION, THE NEEDLE TOOK A FEW SECONDS TO FULLY RETRACT, UNLIKE OTHER BATCHES WHERE THE NEEDLE RETRACTS IMMEDIATELY. DESCRIBE IMPACT TO PATIENT, HCP, USER OR OTHER, INCLUDING RECOVERY, IF APPLICABLE? UPON CHECKING 3¿5 PIECES FROM THE SAME BATCH AND LOT NUMBER, THE SUPERVISOR DECIDED TO ESCALATE AND FORMALLY REPORT THE INCIDENT. ACCORDING TO THE END USERS, THE DELAYED NEEDLE RETRACTION CAUSED STRESS FOR BOTH NURSES AND PATIENTS. THEY ALSO EXPRESSED CONCERN REGARDING THE AFFECTED BATCH AND REQUESTED ITS REPLACEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301839 ↗
Other Becton, Dickinson And Company products
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- BD Luer-Lok48 models · 5,117 reports
- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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