Insyte Autoguard BC ProRecalls & reported problems across all models
Becton, Dickinson And Company · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 10 models of Insyte Autoguard BC Pro by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2020 and Dec 28, 2025 — classified as 1 death, 60 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (23 reports).
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
Most reported Insyte Autoguard BC Pro problems
Device problems
- Retraction Problem23
- Leak/Splash16
- Break5
- Device Contamination with Chemical or Other Material5
- Fluid/Blood Leak4
- Crack3
- Defective Component3
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient3
- Needle Stick/Puncture2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Patient Involvement1
- Perforation of Vessels1
Insyte Autoguard BC Pro models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Insyte Autoguard BC Pro 392523Catheter, intravascular, therapeutic, short-term less than 30 days22 reports
- Insyte Autoguard BC Pro 392533Catheter, intravascular, therapeutic, short-term less than 30 days10 reports
- Insyte Autoguard BC Pro 392534Catheter, intravascular, therapeutic, short-term less than 30 days7 reports
- Insyte Autoguard BC Pro 392623Catheter, intravascular, therapeutic, short-term less than 30 days7 reports
- Insyte Autoguard BC Pro 392633Catheter, intravascular, therapeutic, short-term less than 30 days7 reports
- Insyte Autoguard BC Pro 392537Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- Insyte Autoguard BC Pro 392634Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- Insyte Autoguard BC Pro 392654Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- Insyte Autoguard BC Pro 392512Catheter, intravascular, therapeutic, short-term less than 30 days1 death1 report
- Insyte Autoguard BC Pro 392637Catheter, intravascular, therapeutic, short-term less than 30 days1 report
Recent Insyte Autoguard BC Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2025Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT WHEN SAFETY ACTIVATION BUTTON WAS PUSHED. HCP NEEDLESTICK INJURY OCCURRED USING PRODUCT.
Patient problems: Needle Stick/Puncture
MAUDE report 23903516 ↗MalfunctionJan 29, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21269962 ↗MalfunctionJan 28, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21258675 ↗MalfunctionApr 25, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO REACH OUT TO YOU ABOUT OUR IV CATHETERS FROM BD. I HAVE RECEIVED MULTIPLE COMPLAINTS ABOUT THE CATHETER NOT RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181783 ↗MalfunctionApr 23, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO INCOMPLETE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY MECHANISM DID NOT WORK AS INTENDED. NEEDLE DID NOT RETRACT ALL THE WAY INTO THE HOUSING LEAVING THE CONTAMINATED SHARP EXPOSED.
Patient problems: Needle Stick/Puncture
MAUDE report 19169763 ↗MalfunctionApr 2, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WOULD NOT SAFETY CUSTOMER RESPONSE ON MARCH 15, 2024. 1. RN INSERTED THE DEVICE AND UPON SEEING BLOOD RETURN, ADVANCED SLIGHTLY AND PUSHED WHITE BUTTON TO RETRACT NEEDLE. DESPITE A FEW ATTEMPTS, NEEDLE DID NOT RETRACT. RN TRIED TO MANUALLY FORWARD CATHETER INTO VEIN AND COULD NOT. REMOVED DEVICE ENTIRELY AND CALLED MANAGER (MYSELF) TO LOOK. 2. NO INJURY, BUT NEEDLE EXPOSED AND PATIENT HAD TO HAVE NEW IV STARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19028303 ↗MalfunctionJan 29, 2024Crack; Crack
IT WAS REPORTED THAT A BD INSYTE AUTOG BC GRN 18GA X 1.16IN CATHETER CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENTS HAVE TO HAVE IV'S REPLACED BECAUSE THEY ARE GOING BAD. MANY OF THOSE ARE DUE TO CATHETER DAMAGE. ON MANY OF THEM THE CATHETER WILL CRACK RIGHT NEXT TO THE HUB CAUSING THEM TO LEAK UNDER THE DRESSING. PATIENTS ARE HAVING TO BE STUCK 5-6 TIMES EACH TIME THEY NEED TO REPLACE AN IV.: HELLO (B)(6), SO OVER THE PAST FEW WEEKS, I HAVE NOTICED THAT I PERSONALLY HAVE HAD A BIG INCREASE IN THE NUMBER OF IV'S THAT ARE GOING BAD ON MY SHIFT. THERE HAVE BEEN A COUPLE DAYS WHERE 3 OF MY 5 PATIENTS HAVE TO HAVE IV'S REPLACED BECAUSE THEY ARE GOING BAD. MANY OF THOSE ARE DUE TO CATHETER DAMAGE. ON MANY OF THEM THE CATHETER WILL CRACK RIGHT NEXT TO THE HUB CAUSING THEM TO LEAK UNDER THE DRESSING. IN ADDITION, I HAVE NOTICED THAT THE IV SUPPLIES THAT WE ARE USING ARE NOT GREAT. THEY ARE VERY DIFFICULT TO INSERT. I AM NOT SURE HOW TO PUT IT, BUT IT ALMOST FEELS LIKE THEY CATHETER WON'T SLIDE AGAIN THE SKIN. IT JUST STICKS TO IS LIKE IT NEEDS LUBRICATED TO SLIDE INTO THE SKIN. COMPARED TO THE MATERIALS THAT I USED AT BATHESDA NORTH, I'VE NEVER HAD SO MU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595912 ↗MalfunctionJan 25, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18581272 ↗MalfunctionJan 16, 2024Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18522680 ↗MalfunctionJan 13, 2024Break; Break
IT WAS REPORTED THAT IAG BC PRO WING PNK 20GA X 1.0IN WAS LEAKING AND CRACKED AT THE HUB. IT WAS REPORTED BY CUSTOMER THAT IV WAS INSERTED SUCCESSFULLY IN PATIENT. ONCE INSERTED AND HOOKED UP TO IV FLUIDS, RN NOTICED IV WAS LEAKING UNDER DRESSING, AND THEN NOTICED IV HUB WAS BROKEN / CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509522 ↗MalfunctionJan 7, 2024Retraction Problem; Retraction Problem
MalfunctionJan 5, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD AG BC PRO NEEDLE WAS SLOW OR DIFFICULT TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MDR REFERS TO SENTENCE 2. FROM THE CUSTOMER: EARLIER THIS WEEK I STARTED A FREEHAND PERIPHERAL STICK. I HAD NOT USED THE NEW CATHETERS ON A REAL PATIENT, SO I GRABBED ONE TO PRACTICE TO REMEMBER HOW TO THREAD THE CATHETER AND RETRACT THE NEEDLED. WHEN I DID THAT (IN THE AIR) THE BUTTON WAS PUSHED IN AND LOCKED, HOWEVER THE NEEDLE DID NOT RETRACT BACK. I FIGURED IT WAS A ONE-OFF. WHEN I ACTUALLY STARTED THE IV ON THE PT, THE SAME THING HAPPENED, EXCEPT I WAS ABLE TO PUSH HARDER ON THE BUTTON AND THEN THE NEEDLE RETRACTED BACK. IT WAS ALMOST LIKE THE BUTTON GOT JAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451255 ↗MalfunctionJan 5, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MDR REFERS TO PART ONE OF THE STATEMENT. FROM THE CUSTOMER: EARLIER THIS WEEK I STARTED A FREEHAND PERIPHERAL STICK. I HAD NOT USED THE NEW CATHETERS ON A REAL PATIENT, SO I GRABBED ONE TO PRACTICE TO REMEMBER HOW TO THREAD THE CATHETER AND RETRACT THE NEEDLED. WHEN I DID THAT (IN THE AIR) THE BUTTON WAS PUSHED IN AND LOCKED, HOWEVER THE NEEDLE DID NOT RETRACT BACK. I FIGURED IT WAS A ONE-OFF. WHEN I ACTUALLY STARTED THE IV ON THE PT, THE SAME THING HAPPENED, EXCEPT I WAS ABLE TO PUSH HARDER ON THE BUTTON AND THEN THE NEEDLE RETRACTED BACK. IT WAS ALMOST LIKE THE BUTTON GOT JAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18450620 ↗MalfunctionDec 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD IAG BC PRO APPEARS TO HAVE RUST ON THE INSIDE OF THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. ISSUE1: LOOKS LIKE IT HAS RUSTING ON THE INSIDE OF THE CATHETER. SAMPLE AVAILABLE PT IMPACT: NO. DOE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18394678 ↗MalfunctionDec 19, 2023Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18361006 ↗
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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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