BD Insyte Autoguard 382557Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903825578), received between Dec 6, 2017 and Jul 28, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROACTIVELY TESTED PRODUCT FOR RETRACTION ISSUES AND THEY FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636182 ↗
• InjuryApr 21, 2025Break; Leak/Splash; Material Separation; Break; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877225 ↗
• MalfunctionFeb 26, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472072 ↗
• MalfunctionFeb 26, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE ONLY PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING THAT DEVICE IS NOT FULLY RETRACTING AND LEAVING AN EXPOSED NEEDLE THAT IS DANGEROUS TO THE CLINICIAN AND PATIENT. DATES ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471849 ↗
• MalfunctionJun 11, 2018Degraded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE ADHESIVE ON THE PACKAGING SEAL OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER APPEARS DEGRADED. THEREFORE, THE PRODUCT IS NO LONGER STERILE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588655 ↗
• MalfunctionDec 6, 2017Material Disintegration; Loose or Intermittent Connection; Peeled/Delaminated; Retraction Problem; Self-Activation or Keying; Device Inoperable

  IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND BEFORE USE WITH SEVERAL MALFUNCTIONS. THE GLUE APPEARED DISINTEGRATED ON THE PACKAGES EDGES AS ¿THE PEEL APART EDGES WERE CURLED BACK AND PACKAGES APPEARED TO BE SPONTANEOUSLY OPENING¿ THIS CREATING A STERILE BARRIER BREACH. A SAFETY FAILURE WAS FOUND AS ¿THE ACTIVATION OF THE MECHANICAL BUTTON DOES NOT APPEAR TO RETRACT THE STYLET INTO THE SAFETY BARREL WITHOUT RESISTANCE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089437 ↗

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-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-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-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-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-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-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-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-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