BD Insyte Autoguard 382512Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00382903825127), received between Jun 1, 2018 and Jun 8, 2026 — classified as 5 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (51 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 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Nonstandard Device

  VERBATIM: IV CATHETERS ARE VERY THIN AND FLIMSY, IT IS VERY DIFFICULT TO THREAD THE PLASTIC CATHETER WITHOUT BLOWING THE VEINS ON OUR FRAGILE CHEMO VEINS. EVERY TIME I'VE USED THESE NEEDLES, I BLOW THE VEIN AND THE PATIENT HAS TO BE STUCK AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430568 ↗
• MalfunctionMay 28, 2026Retraction Problem

  NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319998 ↗
• MalfunctionMay 28, 2026Retraction Problem

  BD INSTYLE AUTOGUARD BC NEEDLE FAILED TO RETRACT AFTER NURSE USED IT ON PATIENT. INFUSION CENTER MANAGER AND CHARGE NURSE RANDOMLY SELECTED ANOTHER FROM THE SAME LOT AND THE RETRACTOR STUCK AGAIN, BUT WITH ADDITIONAL PRESSING FINALLY RETRACTED. ALL NEEDLES WITH THIS LOT# WERE PULLED FROM THE FLOOR AND BACKSTOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319982 ↗
• MalfunctionMay 12, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON A NEEDLE. A NURSE WAS ABOUT TO START AN IV ON A PATIENT AND UNCAPPED THE NEEDLE TO SEE ¿SOMETHING DARK¿ ATTACHED TO THE NEEDLE TIP. MAY EVEN BE A BUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154226 ↗
• MalfunctionMay 11, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137105 ↗
• MalfunctionMay 7, 2026Retraction Problem

  IT WAS REPORTED THAT NEEDLES DO NOT RETRACT. THIS EVENT REPRESENTATIVE OF SAMPLE DEVICE TESTING. ON (B)(6) 2026 WE HAD ONE NEEDLE FAIL TO RETRACT AFTER USE AND A SECOND, DRAWN AT RANDOM, BUT FROM THE SAME LOT#, FAIL TO SMOOTHLY RETRACT TOO. ADDITIONAL INFORMATION 4/29/2026: WE HAD A NEEDLE NOT RETRACT AFTER USE. WE THEN RANDOMLY SAMPLED ANOTHER NEEDLE FROM THE SAME LOT AND THAT NEEDLE FAILED TO RETRACT SMOOTHLY. IT RETRACTED BUT HUNG UP AND HAD TO BE MANIPULATED MORE THAN NORMAL. GIVEN THE FAILURE AND THE RANDOM SAMPLE NOT FUNCTIONING SMOOTHLY AND DUE TO RECENT NEEDLE STICK IN THE DEPARTMENT, WE CHOSE TO REMOVE THIS LOT FROM FLOOR STOCK AND BACK STOCK TO PREVENT INJURY. PREVIOUSLY NEEDLE STICK WAS NOT RELATED TO THIS NEEDLE ISSUE, BUT BY NOT RETRACTING PROPERLY IT COULD LEND ITSELF TO A REPEAT OF THE RECENT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113490 ↗
• MalfunctionMay 7, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113475 ↗
• MalfunctionMay 4, 2026Retraction Problem

  IT WAS REPORTED THAT NEEDLES DO NOT RETRACT. ON (B)(6) 2026 WE HAD ONE NEEDLE FAIL TO RETRACT AFTER USE AND A SECOND, DRAWN AT RANDOM, BUT FROM THE SAME LOT#, FAIL TO SMOOTHLY RETRACT TOO. ADDITIONAL INFORMATION 4/29/2026: WE HAD A NEEDLE NOT RETRACT AFTER USE. WE THEN RANDOMLY SAMPLED ANOTHER NEEDLE FROM THE SAME LOT AND THAT NEEDLE FAILED TO RETRACT SMOOTHLY. IT RETRACTED BUT HUNG UP AND HAD TO BE MANIPULATED MORE THAN NORMAL. GIVEN THE FAILURE AND THE RANDOM SAMPLE NOT FUNCTIONING SMOOTHLY AND DUE TO RECENT NEEDLE STICK IN THE DEPARTMENT, WE CHOSE TO REMOVE THIS LOT FROM FLOOR STOCK AND BACK STOCK TO PREVENT INJURY. PREVIOUSLY NEEDLE STICK WAS NOT RELATED TO THIS NEEDLE ISSUE, BUT BY NOT RETRACTING PROPERLY IT COULD LEND ITSELF TO A REPEAT OF THE RECENT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070618 ↗
• MalfunctionMar 30, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730001 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714893 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714294 ↗
• MalfunctionFeb 26, 2026Product Quality Problem; Material Integrity Problem

  CATHETER IS FLIMSY ON INSERTION ADDITIONAL INFORMATION 1/28/26 ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADDITIONAL INFORMATION 1/29/26 CLARIFIES AND CONFIRMS THE NEED FOR THIS MDR: I HAVE HAD THE CATHETER SHEAR SEVERAL TIMES WHEN TRYING TO THREAD THE ANGIOCATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457462 ↗
• MalfunctionJan 12, 2026Manufacturing, Packaging or Shipping Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039852 ↗
• MalfunctionOct 29, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  CATHETER SPLIT FROM THE NEEDLE WHEN INSERTED INTO VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418752 ↗
• MalfunctionAug 15, 2025Retraction Problem; Retraction Problem

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER INJURY OR HARM: NO. THE NEEDLE DID NOT RETRACT. THIS RESULTED IN THE REMOVAL OF A CONTAMINATED SHARP FROM THE PATIENT, REQUIRING A SECOND IV INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818701 ↗
• MalfunctionJul 28, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DOES NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURY OR HARM: NO THE 24G BD INSYTE (MFR# 382512) FAILED TO ADVANCE AND THE NEEDLE DID NOT RETRACT. THIS RESULTED IN THE REMOVAL OF A CONTAMINATED SHARP FROM THE PATIENT, REQUIRING A SECOND IV INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22634637 ↗
• 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: IT WAS REPORTED THAT A 24G BD INSYTE MFR#: (B)(4) WOULD NOT ADVANCE NOR WOULD THE NEEDLE RETRACT, RESULTING IN HAVING TO REMOVE A SHARP FROM THE PATIENT WITH THE EXPOSED CONTAMINATED SHARP END NOT RETRACTED AND THE PATIENT HAD TO BE RE-STUCK FOR IV ACCESS. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 29-06-2025. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? DID NOT RETRACT AT ALL. DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? THE NEEDLE DID NOT RETRACT AT ALL, LEAVING THE NEEDLE COMPLETELY EXPOSED. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? CORRECT. DID THE BUTTON DEPRESS? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632317 ↗
• MalfunctionJul 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M REACHING OUT A SAFETY INCIDENT THAT INVOLVED BD ITEM # 382512 (INSYTE AUTOGUARD BC SHIELDED IV CATHETERS, WINGLESS, YELLOW, 24G X 0.75"). PLEASE SEE NOTEWORTHY EVENT DETAILS BELOW: DESCRIPTION: MOLD VS. STAINING NOTED ON NEEDLE RETRACTION BUTTON ON 24G STRAIGHT BD INSYTE AUTOGUARD BC IV, THAT NEEDLE WAS NOT USED ON PATIENT, NEW IV PACKAGE FROM DIFFERENT LOT # WAS USED. THAT NEEDLE AND PACKAGING (AS WELL AS ALL 24G IV FROM THAT LOT #) WAS REMOVED AND SAVED FOR FURTHER INVESTIGATION. MANAGEMENT WAS EMAILED TO MAKE AWARE. EQUIPMENT: 25G X 0.75 IN (0.7 X 19 MM) BD INSYTE AUTOGUARD BC, EXPIRATION DATE: 2025-12-31, LOT #: 3005946. MANUFACTURE DATE: 2023-01-01. THE EVENT OCCURRED ON 3/31/2025. HARM LEVEL: NO HARM TO PATIENT OR CLINICAL STAFF, AS PRODUCT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501562 ↗
• MalfunctionJul 8, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE AUTOG BC CATHETER DAMAGED, HOLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: HOLE IN CATHETER. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436922 ↗
• MalfunctionJul 7, 2025Activation Problem; Activation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414306 ↗
• MalfunctionJun 30, 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: WE ARE HAVING ISSUES WITH 24-GUAGE NEEDLES WHEN HITTING THE SAFETY/RETRACTION BUTTON. IT'S NOT ALWAYS RETRACTING. I DO NOT HAVE A DATE OF THE EVENT AND THERE WE NO ISSUES WITH ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366244 ↗
• MalfunctionJun 17, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248143 ↗
• MalfunctionJun 17, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IDENTIFIED THAT THE NEEDLE MAY BE SLOW TO RETRACT OR MAY FAIL TO RETRACT ENTIRELY DURING USE. THIS POSES A POTENTIAL SAFETY CONCERN AND COULD IMPACT BOTH PATIENT AND STAFF SAFETY. I HAVE SEEN SIMILAR PRODUCTS COME UP ON A RECALL REPORT BUT NOT THIS EXACT ONE. I AM HOPING YOU CAN HELP WITH NEXT STEPS. THIS HAS BEEN HAPPENING PERIODICALLY OVER THE PAST MONTH OR SO. ON 6/11/2025 WE FORTUNATELY DID NOT HAVE ANY PATIENT HARM OR INJURY. NURSING REPORTED COMPLICATIONS AND NEGATIVE OUTCOMES. WHEN THE NEEDLE WOULD NOT RETRACT THE NURSE HAD TO REMOVE THE NEEDLE AND THE CATHETER AND RE-INSERT A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248101 ↗
• MalfunctionJun 12, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED BY CUSTOMER THAT ONCE CATHETER IS INSERTED AND THEY PRESS THE SAFETY BUTTON, THE NEEDLE DOES NOT RETRACT. VERBATIM: MATERIAL # 382512, BATCH # 4276449. SIMILAR TO THE RECENT IAG / IAGBC RECALL WITH OTHER SKU'S, THE CLINICIANS REPORT THAT ONCE CATHETER IS INSERTED AND THEY PRESS THE SAFETY BUTTON, THE NEEDLE DOES NOT RETRACT. THIS HAPPENED THREE TIMES IN THE PAST DAY WITH THIS SKU/ THIS LOT #. CUSTOMER RESPONSE ON 29-MAY-2025. 1. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO. 2. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NO, IT DID NOT RETRACT. 3. DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? NO. 4. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? CORRECT. 5. DID THE BUTTON DEPRESS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197786 ↗
• MalfunctionJun 12, 2025Retraction Problem; Retraction Problem

  EVENT DETAILS: IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE NOT RETRACTING AS LIKE IT SHOULD. VERBATIM: MATERIAL # 382512 BATCH # 4312504 I HAVE RECENTLY HAD A COUPLE DEPARTMENTS BRING BACK NEEDLE 382512 DUE TO IT NOT RETRACTING THE NEEDLE LIKE IT SHOULD. THEY HAVE OPENED AND TRIED QUITE A FEW THAT HAVE THE SAME ISSUE. THESE ALL SEEM TO BE IN THE SAME LOT (4312504). NO PATIENT IMPACT HAS BEEN DESCRIBED BY THE CUSTOMER, HOWEVER, THERE IS AN INCREASED WORRY FROM THE CLINICIANS ON NEEDLE STICK INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196569 ↗

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-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-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-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-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-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-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-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