BD Insyte Autoguard 381544Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903815449), received between Dec 21, 2017 and Aug 20, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Retraction Problem; Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853449 ↗
• MalfunctionNov 4, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600618 ↗
• MalfunctionNov 6, 2023Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073472 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN CATHETER HUB IS CHIPPED AND UNABLE TO CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB OF CATHETER WAS CHIPPED AND UNABLE TO SCREW ONTO IV EXTENSION SET. 1.COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE?: HUB OF CATHETER WAS CHIPPED AND UNABLE TO SCREW ONTO IV EXTENSION SET 2.WHAT WAS THE IMPACT TO THE PATIENT?: PATIENT NEEDED TO BE STUCK TWICE FOR IV PLACEMENT. 3. PLEASE CONFIRM A PRODUCT IS STILL OPERABLE OR NOT?: NEEDED TO USE ANOTHER ANGIOCATH. 4. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER?: YES, A PATIENT WAS INVOLVED. 5.WHETHER ISSUE IDENTIFIED BEFORE OR AFTER THE EVENT?: ISSUE WAS IDENTIFIED WHEN THE CATHETER WOULD NOT SCREW INTO THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044594 ↗
• MalfunctionOct 10, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DID NOT RETRACT WHEN I HIT THIS BUTTON TO ACTIVATE THE SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909375 ↗
• MalfunctionMay 26, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED BY CUSTOMER THAT WHILE ESTABLISHING AND IV ON PATIENT THE SAFETY ON THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER DID NOT RETRACT COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WHILE ESTABLISHING AND IV ON PATIENT THE SAFETY ON THE BD INSYTE AUTO GUARD IV CATHETER DID NOT COMPLETELY ENGAGED LEAVING THE NEEDLE EXPOSED AND RISK FOR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014007 ↗
• MalfunctionSep 8, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY PREOP NURSE MANAGER STATES THE NEEDLE IS NOT RETRACTING INTO THE SAFETY HUBS ON THE CATHETER IV INSYTE PRODUCTS, AND THIS HAPPENING FREQUENTLY WITH HER STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442576 ↗
• MalfunctionJul 21, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BROKE FROM THE HUB DURING USE AND WAS "BENT/SMASHED." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED TO REPORT THAT A COUPLE OF NURSES HAVE BROUGHT CATHETERS TO HER STATING THAT THEY DON'T ADVANCE AND THE CATHETERS ARE EITHER BORKEN AT THE TIP OR BENT/SMASHED. SHE WAS UNABLE TO PROVIDE DATES OR PATIENT IDENTIFIERS, SHE STATED IT HAS HANPPENED A HANDFUL OFF TIMES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301878 ↗
• MalfunctionApr 23, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WAS PARTIALLY RETRACTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381544 BATCH NO: 9241791 EVENT DESCRIPTION: WE HAD AN ISSUE WITH ONE OF THE BD #18G IV INSYTE AUTOGUARD WINGED CATH NDL ¿ REF #381544. ACCORDING TO THE STAFF MEMBER USING THE #18G IV CATH NEEDLE, AFTER THE STICK THE SAFETY RETRACTION DID NOT FULLY RETRACT LEAVING A PORTION OF THE NEEDLE EXPOSED AND PLACING THE STAFF AT RISK FOR EXPOSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9990341 ↗
• MalfunctionMar 30, 2020Break; Break

  IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN NEEDLE BROKE OFF IN THE CATHETER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544 BATCH NO.: 9198681. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE PLASTIC CATHETER WHILE THE RN WAS ATTEMPTING TO INSERT IT INTO THE PATIENT. WHEN SHE WENT TO PULL THE NEEDLE OUT BY RETRACTING IT, THERE WAS NO NEEDLE ATTACHED AT THE HUB. IT WAS NOTICED REMAINING IN THE CATHETER AND EVERYTHING WAS REMOVED IMMEDIATELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9900764 ↗
• MalfunctionMar 17, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544. BATCH NO.: UNKNOWN. CALLED CUSTOMER AND FOUND OUT THE INCIDENT DATE AND THAT THE CATHETER WAS USED FOR CHEMOTHERAPY MEDICINE. SHE DID NOT KNOW THE LOT NUMBER AND HAD NO PATIENT INFORMATION TO PROVIDE BUT STATED IT HAPPENED DURING USE AND HAD NO ISSUES OTHER THAN THE PHYSICAL DEFECT. SURGERY BROUGHT THIS TO MY ATTENTION. THERE IS A LITTLE TAB OFF THE SIDE THAT LOOKS LIKE AN ANOMALY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9838660 ↗
• MalfunctionMar 13, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETERS 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544, BATCH NO.: 9113561. PER COMPLAINT FORM: NURSE REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHEN BUTTON TO RETRACT WAS PUSHED. EVEN WHEN SHE BROUGHT IT OUT, IT STILL WOULD NOT RETRACT. SECOND NURSE REPORTED THIS HAS ALSO HAPPENED TO HER RECENTLY. BOTH NURSES WERE USING A 18 GUAGE (REF 381544) INSYTE AUTOGUARD IV CATHETER. THE LOT NUMBER FOR THE ONE THAT MALFUNCTIONED TONIGHT IS 9113561.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9828443 ↗
• MalfunctionMar 9, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544, BATCH NO.: 9113561. PER EMAIL: EMPLOYEE HARED WITH ME THAT A PSN (PATIENT SAFETY NETWORK) WAS LOGGED ON AN INSYTE CATHETER THAT WOULD NOT RETRACT THE NEEDLE. WHILE I AM ONLY AWARE OF THIS ONE PSN, THERE IS APPARENTLY ANOTHER INCIDENT REPORTED BY A DIFFERENT NURSE. I BELIEVE BOTH OF THESE INCIDENTS HAVE OCCURRED AT THE WOMEN'S AND CHILDREN'S USER FACILITY. THE MATERIAL # IS 381544 AND THE LOT NUMBER IS 9113561 BOTH INCIDENTS WERE 18GA. RIGHT NOW THEY ARE MONITORING TO OBSERVE ANY TRENDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806246 ↗
• MalfunctionFeb 10, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  WAS REPORTED THAT THEE WAS AN INCIDENT WITH THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN DURING USE THE WINGS ADAPTER SEPARATED AND REQUIRED MEDICAL INTERVENTION. MATERIAL NO.: 381544, BATCH NO.: 9198681. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THAT THERE WAS AN INCIDENT WITH THIS PRODUCT AND THE PATIENT HAD TO HAVE A MRI TO LOCATE THE SHEATH. IT WAS CLARIFIED THAT THE WINGED ADAPTER SEPARATED FROM THE CATHETER WHEN INSERTED INTO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9688045 ↗
• MalfunctionFeb 3, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CANNULA CAME APART DURING THE NIGHT AND REMAINED IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE NIGHT A CANNULA FROM AN IV CATHETER CAME APART AND THE PLASTIC CANNULA WAS LEFT IN THE PATIENT."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9662642 ↗
• MalfunctionAug 5, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD EXPERIENCED CATHETER KINKING/BENT DURING INFUSION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381544, BATCH NO: 7201997. EVENT DESCRIPTION: DIFFICULTY THREADING THE CATHETER. COULD NOT TREAT BECAUSE CATHETER WOULD NOT FLUSH DUE TO BENDING. CUSTOMER CONFIRMED BENDING OCCURRED DURING PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859773 ↗
• MalfunctionJul 30, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 381544 BATCH NO. 8278868. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CATHETER NEEDLE HUB WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDED SECOND IV START. THE GREEN HUB WAS BROKEN. THE PRODUCT HAS BEEN DISCARDED UNFORTUNATELY. FIRST TIME OCCURRENCE HAS BEEN BROUGHT TO MANAGERS ATTENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841419 ↗
• MalfunctionJun 18, 2019Retraction Problem; Material Protrusion/Extrusion; Retraction Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DIFFICULT TO RETRACT AS THE SPRING APPEARED TO BE MALFUNCTIONING, WHICH IN TURN CAUSED BLOOD TO SPLATTER OUT AND ONTO THE PATIENT AND NURSE'S CLOTHING. THERE WAS NO EXPOSURE TO MUCOSAL MEMBRANE, AND MEDWATCH REPORT# MW 5086636 WAS OPENED AND FILED IN RESPONSE TO THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I PLACED 18 GAUGE INSYTE AUTOGUARD IV. WHEN NURSE RETRACTED NEEDLE, SPRING APPEARED TO MALFUNCTION CASING BLOOD SPATTER TO PT AND TO NURSE'S CLOTHING. THERE WAS NO HARM, THE NURSE DID NOT SUSTAIN BLOOD EXPOSURE TO THE SKIN OR MUCOUS MEMBRANES. NO TESTING COMPLETED ON THE NURSE, NO INTERVENTIONS PROVIDED TO THE NURSE. FDA SAFETY REPORT ID# (B)(4)".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708662 ↗
• MalfunctionJun 3, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON INSERTION THE CATHETER SPLIT AND BENT INSIDE PATIENT WITH A BD INSYTE¿ AUTOGUARD¿ WINGED GN 18GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN INSERTING CATHLON INTO PATIENT, NEEDLE PIECED THROUGH THE PLASTIC CATHLON AND THE CATHLON SPLIT/BENT INSIDE THE PATIENT, CAUSING BLEEDING, SWELLING AND PAIN. THIS HAPPENED DURING AN EMERGENCY EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling

  MAUDE report 8663584 ↗
• MalfunctionFeb 8, 2018Retraction Problem

  IT WAS REPORTED AFTER USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE FAILED TO FULLY RETRACT INTO THE SAFETY SHIELD. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252631 ↗
• MalfunctionDec 21, 2017Fail-Safe Design Failure

  IT WAS REPORTED THAT THE SAFETY MECHANISM ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO FUNCTION PROPERLY, LEAVING THE NEEDLE EXPOSED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7137147 ↗

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-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-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-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-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-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-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-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-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-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-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