Insyte Autoguard 382944Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903829446), received between Sep 26, 2022 and Sep 4, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. 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-2003-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Retraction Problem; Retraction Problem

  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 22969601 ↗
• MalfunctionJun 12, 2025Retraction Problem; Retraction Problem

  CLARIFICATION RECEIVED: ON 1-JUL-25 ¿ COMPLAINT TO BE CANCELLED. NOT A COMPLAINT FROM A CUSTOMER. THE SALES REP ONLY SHARES THE RECENT FIELD ACTION MDS_25_5274 AS IT SUSPECTED COMPLAINT WAS RELATED TO THIS FSCA. INTAKE TEAM ERRONEOUSLY CREATED NEW COMPLAINTS RESULTING IN MULTIPLE MDRS BASED ON THE BD FIELD ACTION DOCUMENT.

  Patient problems: Insufficient Information

  MAUDE report 22198120 ↗
• MalfunctionJun 12, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD HAS DETERMINED THAT WHEN INSERTING THE CATHETER, THE NEEDLE RETRACTS SLOWLY OR DOES NOT RETRACT AT ALL. SLOW OR NO RETRACTION MAY RESULT IN REPEATED ATTEMPTS TO RETRACT THE NEEDLE BY PRESSING THE BUTTON. IT IS ALSO POSSIBLE THAT A NEEDLE MAY REMAIN EXPOSED DESPITE ATTEMPTS TO COVER IT.

  Patient problems: Insufficient Information

  MAUDE report 22196595 ↗
• MalfunctionApr 25, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913300 ↗
• MalfunctionMar 19, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DESCRIPTION OF THE FACTS, CIRCUMSTANCES AND MEANS USED: THE AUTO-GUARD DEVICE DOES NOT WORK OR RETRACTS VERY SLOWLY. MEASURES TAKEN: 1 YES. FREQUENCY: 5 VERY PROBABLE (MORE THAN ONCE A WEEK). DESCRIPTION OF THE CONSEQUENCES: RISK OF NEEDLE STICK AND SPLASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640867 ↗
• MalfunctionMar 18, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21637915 ↗
• MalfunctionMar 4, 2025Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC GLOBAL WING SLOW NEEDLE RETRACTION WITH BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: FEW UPDATES FROM BD REP "(B)(4)": "TESTED SOME QUARANTINED CATHETERS (REF. 382944). THE SAFETY MECHANISM ENGAGES SLOWLY, AS IF THE BLOOD CONTROL MEMBRANE WERE HOLDING BACK THE MANDREL CANULA. THIS GIVES THE BLOOD TIME TO SQUIRT OUT OF THE CATHETER ADAPTER, POSING A SIGNIFICANT RISK OF NEEDLESTICK INJURY. AT THE SAME TIME, I TOOK A BLOOD CONTROL AUTOGARD CATHETER FROM ANOTHER BATCH THAT I HAD IN MY BAG AND CARRIED OUT THE SAME PROCEDURE. THE CANULA RETRACTED WITHOUT ANY RESISTANCE. I DON'T KNOW IF IT'S THE PROTECTIVE SHEATH THAT HAS A PROBLEM OR RATHER THE BLOOD CONTROL MEMBRANE THAT IS TOO TIGHT AND PREVENTS NORMAL RETRACTION OF THE CANULA. THE CLIENT WILL PUT SEVERAL UNUSED CATHETERS FROM THE OFFENDING BATCH. FOR MY PART, I THINK THAT BOTH ELEMENTS (CATHETER AND SHEATH) SHOULD BE TESTED. THE CLIENT PUT ON A SOILED PROTECTIVE SHEATH BUT NOT THE CATHETER PART BECAUSE THE CAREGIVERS COULD NOT INFUSE THE PATIENTS." PLEASE FIND A REPORT CONCERNING THE DEFECTIVE NATURE OF AUTOGUARD CATHETERS REFERENCE 3829

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517715 ↗
• MalfunctionMar 4, 2025Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517714 ↗
• MalfunctionMar 4, 2025Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC GLOBAL WING SLOW NEEDLE RETRACTION WITH BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: FEW UPDATES FROM BD REP "(B)(4)": "TESTED SOME QUARANTINED CATHETERS (REF. 382944). THE SAFETY MECHANISM ENGAGES SLOWLY, AS IF THE BLOOD CONTROL MEMBRANE WERE HOLDING BACK THE MANDREL CANULA. THIS GIVES THE BLOOD TIME TO SQUIRT OUT OF THE CATHETER ADAPTER, POSING A SIGNIFICANT RISK OF NEEDLESTICK INJURY. AT THE SAME TIME, I TOOK A BLOOD CONTROL AUTOGARD CATHETER FROM ANOTHER BATCH THAT I HAD IN MY BAG AND CARRIED OUT THE SAME PROCEDURE. THE CANULA RETRACTED WITHOUT ANY RESISTANCE. I DON'T KNOW IF IT'S THE PROTECTIVE SHEATH THAT HAS A PROBLEM OR RATHER THE BLOOD CONTROL MEMBRANE THAT IS TOO TIGHT AND PREVENTS NORMAL RETRACTION OF THE CANULA. THE CLIENT WILL PUT SEVERAL UNUSED CATHETERS FROM THE OFFENDING BATCH. FOR MY PART, I THINK THAT BOTH ELEMENTS (CATHETER AND SHEATH) SHOULD BE TESTED. THE CLIENT PUT ON A SOILED PROTECTIVE SHEATH BUT NOT THE CATHETER PART BECAUSE THE CAREGIVERS COULD NOT INFUSE THE PATIENTS." PLEASE FIND A REPORT CONCERNING THE DEFECTIVE NATURE OF AUTOGUARD CATHETERS REFERENCE 3829

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517368 ↗
• MalfunctionDec 1, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY NEEDLE CAUGHT ONTO THE CATHETER DURING THE RETRACTION PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN 18G INSYTE AUTOGAURD BC PRO WINED IV CATHETER DID NOT WORK CORRECTLY. AFTER PIERCING THE SKIN AND VEIN WITH FLASH SEEN, THE CATH OVER NEEDLE WAS ADVANCED A BIT MORE ENSURING IT WAS PLACED PROPERLY IN THE VEIN. THE CATHETER WAS STARTED TO BE ADVANCED OVER THE NEEDLE TO SET IT INTO THE VEIN. THE BUTTON WAS PRESSED SO THE NEEDLE COULD RETRACT, AND WHEN IT RETRACTED IT CAUGHT ONTO THE CATHETER AND PULLED IT OUT OF THE PT'S SKIN, CAUSING BLEEDING AND A LARGE HEMATOMA. IMPACT OF INCIDENT: PRESSURE WAS APPLIED AND ALL INFORMATION ABOUT THE INCIDENT WAS DISCLOSED TO THE PT. THE BLEEDING QUICKLY STOPPED WITH PRESSURE AND GAUZE. WHO WAS AFFECTED? PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899588 ↗
• MalfunctionSep 26, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY NEEDLE WOULD NOT RETRACT AFTER THE INSERTION AS THE SAFETY MECHANISM MALFUNCTIONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WHEN THE CATHETER WAS INSERTED, THE SPRING DID NOT ENGAGE PROPERLY WHEN THE CATHETER WAS RETRACTED. THIS PREVENTED THE CATHETER FROM BEING CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15488914 ↗