BD Insyte Autoguard 382637Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903826377), received between Aug 11, 2021 and Mar 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC CATHETER PACKAGING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A HOLE IN THE PACKAGING WHERE THE BARREL APPEARED TO POP THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592172 ↗
• MalfunctionMar 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC CATHETER HUB AND BARREL WERE SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS UNCLEAR IF THIS WAS DONE BEFORE OR AFTER NOTICING THE HUB AND BARREL APPEAR SEPARATED, BENT, CRUSHED ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592029 ↗
• MalfunctionDec 8, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT WHILE USING A BD INSYTE¿ AUTOGUARD¿ BC CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT OR USER IMPACT.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, NEEDLE DID NOT RETRACT INTO THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965108 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USED AN IV CATH ON HER, INITIALLY GOT GOOD BLOOD RETURN, PLACEMENT VERIFIED BY US BUT THE IT FELT AS THERE WAS AIR COMING INTO THE CATH OR A LEAK. ATTEMPED TO MAKE SURE ALL CONNECTIONS WERE SECURE, NO CHANGE. HAD TO PULL THIS IV AND ESTABLISH ANOTHER ONE. FELT THIS WAS FAULTY CATHETER. DIFFICULT TO ASSESS IF THERE WAS A HOLE IN THE CATHETER AS THERE WAS BLOOD IN THE CATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310795 ↗

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-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-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-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-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-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-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-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