BD Insyte-N Autoguard 381811Recalls & reported problems
Becton, Dickinson And Company · INSYTE-N AUTOGUARD YEL 24GA 0.56IN · Class 2
All models of BD Insyte-N Autoguard (4)
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-N Autoguard catheter is a short-term IV catheter with a safety needle that retracts into the hub after use. Most of the 66 reports describe the needle retracting too slowly or not at all, along with cracks or punctures in the catheter and leaking. One report involved an injury. There is 1 open recall, started in May 2025, over the possibility that the needle may be slow to retract or fail to retract. Reports fell from 40 in the earlier 12 months to 3 in the most recent.
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
- 66
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00382903818112), received between Oct 11, 2019 and Feb 27, 2026 — classified as 1 injury, 65 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (31 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-2004-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Retraction Problem31
- Defective Component8
- Material Puncture/Hole8
- Leak/Splash3
- Break2
- Device Contamination with Chemical or Other Material2
- Material Split, Cut or Torn2
- Nonstandard Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Insufficient Information9
- Pain2
- Infiltration into Tissue1
- Necrosis1
- No Known Impact Or Consequence To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Crack
IT WAS REPORTED THAT CATHETER PRESENTED RESISTANCE WHEN PERFORMING PUNCTURE DUE TO THE PRESENCE OF A CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475626 ↗MalfunctionDec 14, 2025Retraction Problem; Material Split, Cut or Torn; Retraction Problem; Material Split, Cut or Torn
PT WAS RECEIVING 2ND IV ACCESS ATTEMPT DUE TO INITIAL UNSUCCESSFUL ATTEMPT. IV ACCESS USING 24 GAUGE INSYTE AUTOGUARD 0.75 WAS ATTEMPTED. DURING ATTEMPT SS HAD FLASH AND WAS ATTEMPTING TO THREAD CANNULA. SS WAS UNABLE TO THREAD CANNULA. SS STATES THAT THEY HIT FLASH IMMEDIATELY WITH 0 READJUSTMENT OF NEEDLE REQUIRED. AFTER BEING UNABLE TO THREAD, A BUMP WAS NOTED TO IV SITE. NEEDLE WAS NOT RETRACTED AND CANNULA WAS REMOVED WITH NEEDLE IN PLACE. SS NOTED THAT NEEDLE HAD PUNCTURED TOP 1/4 OF CANNULA. CANULA WAS REMOVED INTACT. (B)(6) 2025: THERE WERE NO ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799389 ↗MalfunctionNov 15, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT PROCEED TO PERFORM CANALIZATION BY INFILTRATION OF PREVIOUS ACCESS. ATTEMPT IS MADE AND DAMAGE TO THE CATHETER STRUCTURE IS OBSERVED WHEN REMOVING IT FROM THE VEIN.
Patient problems: Infiltration into Tissue
MAUDE report 23564261 ↗MalfunctionOct 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376287 ↗MalfunctionSep 4, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED BY CUSTOMER THAT DURING INSERTION OF THE CATHETER, THE NEEDLE IS SLOW TO RETRACT OR FAILS TO RETRACT. THE SLOW OR NO RETRACTION MAY REQUIRE REPEATED ATTEMPTS AT RETRACTION OF THE NEEDLE BY PRESSING THE BUTTON. THERE IS ALSO THE POTENTIAL FOR A NEEDLE TO REMAIN EXPOSED, DESPITE SHIELDING ATTEMPTS. EVERY TIME IV IS INSERTED INTO A PATIENT AND THE NEEDLE RETRACTION BUTTON IS PRESS, IT WON'T RETRACT. THIS CAUSES DIFFICULTY TRYING TO KEEP THE IV PATENT WHILE REMOVING THE NEEDLE AND MOST TIMES THE IV WILL NOT STAY IN THE VEIN AS A RESULT. END USERS USES SOMETIMES 2 OR 3 AND EVEN 4 IVS TO GET ONE TO RETRACT AND THE IV STAY IN PATIENT.
Patient problems: Insufficient Information
MAUDE report 22974251 ↗MalfunctionAug 29, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925951 ↗MalfunctionJul 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE WAS SLOW RETRACT DURING DEVICE TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TESTED ONE AND THE BUTTON WOULD NOT ENGAGE INITIALLY AND REQUIRED SEVERAL ATTEMPTS TO HAVE THE BUTTON WORK. (THIS IS A SLOW RETRACTION WITH NO PATIENT INVOLVEMENT 1X). THIS OCCURRED ON (B)(6) 2025. WE FURTHER TESTED OTHER CANNULAS AND THE FAILURE TO RETRACT WAS THE SAME WITH DIFFERENT CANNULAS OF THE SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22545752 ↗MalfunctionJul 18, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22545738 ↗MalfunctionJun 24, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO RETRACT NEEDLE FROM PLASTIC CATHETER. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322194 ↗MalfunctionJun 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT FULLY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 28-MAY-2025 CONCERN DESCRIPTION: DOCTOR ATTEMPTING TO START AN IV FOR A PATIENT, BUT UNABLE TO RETRACT NEEDLE FROM PLASTIC HUB. THIS OCCURRED TWO TIMES. PSLS ID(B)(6). NO ADVERSE EVENT REPORTED. CUSTOMER RESPONSE RECEIVED ON 12-JUNE-2025. THE NEEDLE DID NOT FULLY RETRACT OUT OF THE PLASTIC HUB. THE NEEDLE INITIALLY BEGAN TO RETRACT AT REGULAR SPEED AND THEN STOPPED. YES THE NEEDLE STARTED TO RETRACT AND THEN STOPPED. THE NEEDLE MOVED AND THEN STOPPED. YES THE BUTTON DEPRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293632 ↗MalfunctionJun 12, 2025Retraction Problem; Retraction Problem
MalfunctionJun 12, 2025Retraction Problem; Retraction Problem
MalfunctionJun 4, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF THE OCCURRENCE (DESCRIBE THE DEVIATION OBSERVED, DETAILS, AND OUTCOME OF THE CASE); THE NEEDLE CAME OUT OF THE CATHETER. DATE OF IDENTIFICATION OF THE OCCURRENCE; ON (B)(6) 2025. QUANTITY IDENTIFIED WITH DEVIATION; 01. WHEN WAS THE OCCURRENCE WITH THE PRODUCT IDENTIFIED (BEFORE STARTING THE PROCEDURE, DURING PRODUCT HANDLING BY THE PROFESSIONAL/USER, DURING USE ON THE PATIENT, OR AFTER USE ON THE PATIENT)? DURING HANDLING. WAS THERE ANY HARM TO THE PATIENT, HEALTHCARE PROFESSIONAL, USER, OR OTHERS? (PROVIDE DETAILS)? NO. WAS MEDICAL AND/OR SURGICAL INTERVENTION NECESSARY DUE TO THE OCCURRENCE (IMAGING TESTS, SURGERY, ADMINISTRATION OF MEDICATION, ETC.)? (PROVIDE DETAILS)? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140356 ↗MalfunctionJun 3, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DIFFICULT TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DID NOT RETRACT EASILY WHEN THE RETRACTION BUTTON WAS PUSHED. CUSTOMER RESPONDED ON (B)(6). 1. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? YES, BUT THE BUTTON NEEDED TO BE PRESSED VERY FIRMLY. 2. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NO. 3. DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED? NO. 4. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? INITIALLY YES. IT ONLY MOVED WHEN THE BUTTON WAS PRESSED VERY FIRMLY. 5. DID THE BUTTON DEPRESS? YES, WITH EXCESS FORCE.
Patient problems: Insufficient Information
MAUDE report 22131832 ↗MalfunctionMay 28, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: (B)(6) 2025 CONCERN DESCRIPTION: NEEDLE NOT RETRACTING WHEN BUTTON PRESSED DOWN WITH IV START (B)(6) ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094799 ↗MalfunctionMay 11, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE MANDREL DOES NOT RETRACT WHEN THE BUTTON IS PRESSED. ADDITIONAL INFORMATION RECEIVED: TESTS HAVE BEEN CARRIED OUT WITH OTHER BATCHES AND BATCH 4208538 RETRACTS WITH MUCH GREATER DIFFICULTY THAN THE OTHERS. THIS MADE CATHETER FITTING DIFFICULT FOR THE TEAM. THIS IS A RECURRING PROBLEM WITH THIS BATCH. THE PATIENT HAD TO BE PRICKED 4 TIMES TO PLACE THE PERIPHERAL CATHETER. THE EVENT TOOK PLACE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21999803 ↗MalfunctionMay 10, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE MANDREL DOES NOT RETRACT WHEN THE BUTTON IS PRESSED. ADDITIONAL INFORMATION RECEIVED: TESTS HAVE BEEN CARRIED OUT WITH OTHER BATCHES AND BATCH 4208538 RETRACTS WITH MUCH GREATER DIFFICULTY THAN THE OTHERS. THIS MADE CATHETER FITTING DIFFICULT FOR THE TEAM. THIS IS A RECURRING PROBLEM WITH THIS BATCH. RESPONSE RECEIVED - 07-MAY-2025 THE OTHER TWO EVENTS OCCURRED AROUND (B)(6), BUT I CAN'T GIVE YOU THE EXACT DATE. THERE WAS NO HARM DONE TO EITHER THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21999520 ↗MalfunctionMay 10, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE MANDREL DOES NOT RETRACT WHEN THE BUTTON IS PRESSED. ADDITIONAL INFORMATION RECEIVED: TESTS HAVE BEEN CARRIED OUT WITH OTHER BATCHES AND BATCH 4208538 RETRACTS WITH MUCH GREATER DIFFICULTY THAN THE OTHERS. THIS MADE CATHETER FITTING DIFFICULT FOR THE TEAM. THIS IS A RECURRING PROBLEM WITH THIS BATCH. RESPONSE RECEIVED - 07-MAY-2025 THE OTHER TWO EVENTS OCCURRED AROUND DECEMBER, BUT I CAN'T GIVE YOU THE EXACT DATE. THERE WAS NO HARM DONE TO EITHER THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21999519 ↗MalfunctionMay 9, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DEFECT CAUSES MECHANISM TO STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THE CATHETER WAS IN THE VEIN, AND BLOOD RETURN WAS CONFIRMED, THE CATHETER WAS ADVANCED IN THE VEIN AS NORMAL. UP TO THIS STAGE EVERYTHING WAS FINE. THE ISSUES HAVE ARRIVED AT THE MOMENT THE NURSES NEEDED TO RETRIEVE THE NEEDLE BY PUSHING ON THE WHITE PUSH BUTTON TO RETRACT THE NEEDLE. THE NEEDLE STAYS STUCK ON THE LITTLE WHITE PART OF THE PUSH BUTTON SO WHEN THE THOUGHT THEY SECURELY RETRACTED THE NEEDLE AND PULLED TO RETRIEVE, EVERYTHING CAME OUT, NEEDLE AND CANNULA(CATHETER) WHEN INSTALLING THE JELCO, WHEN REMOVING THE NEEDLE, THE MECHANISM GETS STUCK AND THE CATHETER FOLLOWS WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997198 ↗MalfunctionMay 9, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DEFECT CAUSES MECHANISM TO STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THE CATHETER WAS IN THE VEIN, AND BLOOD RETURN WAS CONFIRMED, THE CATHETER WAS ADVANCED IN THE VEIN AS NORMAL. UP TO THIS STAGE EVERYTHING WAS FINE. THE ISSUES HAVE ARRIVED AT THE MOMENT THE NURSES NEEDED TO RETRIEVE THE NEEDLE BY PUSHING ON THE WHITE PUSH BUTTON TO RETRACT THE NEEDLE. THE NEEDLE STAYS STUCK ON THE LITTLE WHITE PART OF THE PUSH BUTTON SO WHEN THE THOUGHT THEY SECURELY RETRACTED THE NEEDLE AND PULLED TO RETRIEVE, EVERYTHING CAME OUT, NEEDLE AND CANNULA(CATHETER) WHEN INSTALLING THE JELCO, WHEN REMOVING THE NEEDLE, THE MECHANISM GETS STUCK AND THE CATHETER FOLLOWS WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997197 ↗MalfunctionMay 9, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DEFECT CAUSES MECHANISM TO STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THE CATHETER WAS IN THE VEIN, AND BLOOD RETURN WAS CONFIRMED, THE CATHETER WAS ADVANCED IN THE VEIN AS NORMAL. UP TO THIS STAGE EVERYTHING WAS FINE. THE ISSUES HAVE ARRIVED AT THE MOMENT THE NURSES NEEDED TO RETRIEVE THE NEEDLE BY PUSHING ON THE WHITE PUSH BUTTON TO RETRACT THE NEEDLE. THE NEEDLE STAYS STUCK ON THE LITTLE WHITE PART OF THE PUSH BUTTON SO WHEN THE THOUGHT THEY SECURELY RETRACTED THE NEEDLE AND PULLED TO RETRIEVE, EVERYTHING CAME OUT, NEEDLE AND CANNULA(CATHETER). WHEN INSTALLING THE JELCO, WHEN REMOVING THE NEEDLE, THE MECHANISM GETS STUCK AND THE CATHETER FOLLOWS WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997196 ↗MalfunctionMay 9, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DEFECT CAUSES MECHANISM TO STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THE CATHETER WAS IN THE VEIN, AND BLOOD RETURN WAS CONFIRMED, THE CATHETER WAS ADVANCED IN THE VEIN AS NORMAL. UP TO THIS STAGE EVERYTHING WAS FINE. THE ISSUES HAVE ARRIVED AT THE MOMENT THE NURSES NEEDED TO RETRIEVE THE NEEDLE BY PUSHING ON THE WHITE PUSH BUTTON TO RETRACT THE NEEDLE. THE NEEDLE STAYS STUCK ON THE LITTLE WHITE PART OF THE PUSH BUTTON SO WHEN THE THOUGHT THEY SECURELY RETRACTED THE NEEDLE AND PULLED TO RETRIEVE, EVERYTHING CAME OUT, NEEDLE AND CANNULA(CATHETER) WHEN INSTALLING THE JELCO, WHEN REMOVING THE NEEDLE, THE MECHANISM GETS STUCK AND THE CATHETER FOLLOWS WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997191 ↗MalfunctionMay 9, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE DEFECT CAUSES MECHANISM TO STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THE CATHETER WAS IN THE VEIN, AND BLOOD RETURN WAS CONFIRMED, THE CATHETER WAS ADVANCED IN THE VEIN AS NORMAL. UP TO THIS STAGE EVERYTHING WAS FINE. THE ISSUES HAVE ARRIVED AT THE MOMENT THE NURSES NEEDED TO RETRIEVE THE NEEDLE BY PUSHING ON THE WHITE PUSH BUTTON TO RETRACT THE NEEDLE. THE NEEDLE STAYS STUCK ON THE LITTLE WHITE PART OF THE PUSH BUTTON SO WHEN THE THOUGHT THEY SECURELY RETRACTED THE NEEDLE AND PULLED TO RETRIEVE, EVERYTHING CAME OUT, NEEDLE AND CANNULA(CATHETER) WHEN INSTALLING THE JELCO, WHEN REMOVING THE NEEDLE, THE MECHANISM GETS STUCK AND THE CATHETER FOLLOWS WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997190 ↗MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905394 ↗MalfunctionApr 3, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT. INCIDENT DETAILS: WHEN TRYING TO PUSH THE BUTTON TO RETRACT THE NEEDLE FROM THE CATHETER INTO THE GUARD THE BUTTON GOT STUCK, AND THE NEEDLE WAS NOT ABLE TO BE PULLED OUT WITH REASONABLE FORCE. EXCESSIVE FORCE NEEDED TO PULL NEEDLE FROM CATHETER AND THEN NEEDLE AUTO RETRACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763641 ↗
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-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-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-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-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-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-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-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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