Insyte Autoguard BC Pro 392534Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903925346), received between Jul 8, 2021 and Apr 25, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 7, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT PROPERLY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT WOULD NOT SAFETY PROPERLY AND HAD TO PLACE IN THE SHARPS WITHOUT THE SAFETY RETRACTING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317092 ↗
• MalfunctionOct 28, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT ~10 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER EXPERIENCED DIFFICULT NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 20G AUTOGUARD PRO'S ARE SOMETIMES STICKING PRIOR TO ACTIVATING THE SAFETY FOR A SPLIT SECOND. THIS HAPPENED A COUPLE OF TIMES IN THE ED. SAFETY FEATURE IS STILL WORKING THOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691713 ↗
• MalfunctionJul 28, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT AFTER REMOVING IT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE DID NOT RETRACT BACK INTO CATHETER BUT REMAINED FULLY EXTENDED WHICH POSES A POTENTIAL RISK FOR NEEDLE STICK. AFTER REMOVING FROM PATIENT AREA STILL COULD NOT RETRACT NEEDLE. PLACED IN SHARPS BOX AFTER SHOWING TO SUPERVISOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122583 ↗
• MalfunctionSep 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT IAG BC PRO PNK 20GA X 1.16IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BD INSTYE AUTOGUARD AND IT MALFUNCTIONED WHEN ATTEMPTING TO RECOIL NEEDLE, THE BUTTON WOULD NOT RELEASE THE NEEDLE BACK INTO THE HUB, IT APPEARED TO HAVE ADDITIONAL PLASTIC PIECES AROUND THE PINK CATHETER. VERBATIM: WE RECENTLY TRANSITIONED TO YOUR NEW IV CATHS AND I ACTUALLY HAD ONE MALFUNCTION FOR ME YESTERDAY. I WAS PLACING AN IV WITH A 20 GA BD INSTYE AUTOGUARD AND IT MALFUNCTIONED WHEN ATTEMPTING TO RECOIL NEEDLE. THE BUTTON WOULD NOT RELEASE THE NEEDLE BACK INTO THE HUB. MYSELF AND ANOTHER NURSE ATTEMPTED TO MANUALLY REMOVE THE NEEDLE AND IT FELT LIKE THERE WAS SUCTION PRESSURE WHEN PULLING BACK ON THE NEEDLE. EVENTUALLY WE WERE ABLE TO MANUALLY REMOVE THE NEEDLE AND THREAD THE CATHETER, AFTER VISUAL INSPECTING THE IV, THE NEEDLE REMAINED INTACT, HOWEVER IT APPEARED TO HAVE ADDITIONAL PLASTIC PIECES AROUND THE PINK CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508363 ↗
• MalfunctionSep 21, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT IAG BC PRO PNK 20GA X 1.16IN NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BD INSTYE AUTOGUARD AND IT MALFUNCTIONED WHEN ATTEMPTING TO RECOIL NEEDLE, THE BUTTON WOULD NOT RELEASE THE NEEDLE BACK INTO THE HUB, IT APPEARED TO HAVE ADDITIONAL PLASTIC PIECES AROUND THE PINK CATHETER. VERBATIM: WE RECENTLY TRANSITIONED TO YOUR NEW IV CATHS AND I ACTUALLY HAD ONE MALFUNCTION FOR ME YESTERDAY. I WAS PLACING AN IV WITH A 20 GA BD INSTYE AUTOGUARD AND IT MALFUNCTIONED WHEN ATTEMPTING TO RECOIL NEEDLE. THE BUTTON WOULD NOT RELEASE THE NEEDLE BACK INTO THE HUB. MYSELF AND ANOTHER NURSE ATTEMPTED TO MANUALLY REMOVE THE NEEDLE AND IT FELT LIKE THERE WAS SUCTION PRESSURE WHEN PULLING BACK ON THE NEEDLE. EVENTUALLY WE WERE ABLE TO MANUALLY REMOVE THE NEEDLE AND THREAD THE CATHETER, AFTER VISUAL INSPECTING THE IV, THE NEEDLE REMAINED INTACT, HOWEVER IT APPEARED TO HAVE ADDITIONAL PLASTIC PIECES AROUND THE PINK CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508013 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem

  IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETER SEPARATED WHILE RETRACTING AND BLOOD SPLASH OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS BLOOD BACKSPLASH AND THE CATHETER SEPARATED WHEN THE NEEDLE RETRACTED (NEEDLE SNAGGING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140188 ↗

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, Classified
  REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
• Z-1999-2025 · May 21, 2025 · Open, Classified
  REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
• Z-2007-2025 · May 21, 2025 · Open, Classified
  REF: 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, Classified
  REF: 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-2003-2025 · May 21, 2025 · Open, Classified
  REF: 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-2006-2025 · May 21, 2025 · Open, Classified
  REF: 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-2001-2025 · May 21, 2025 · Open, Classified
  REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
• Z-2005-2025 · May 21, 2025 · Open, Classified
  REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
• Z-2004-2025 · May 21, 2025 · Open, Classified
  REF: 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, Classified
  BD 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, Classified
  BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533