BD Insyte Autoguard 382537Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00382903825370), received between Apr 2, 2019 and Apr 28, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Leak/Splash

  IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE DID NOT WORK. A CUSTOMER REACHED OUT TO LET US KNOW THAT ITEMS 382537 AND 382523 ARE HAVING ISSUES WITH BLOOD CONTROL. ALTHOUGH BOTH ITEMS ARE LABELED AS BLOOD CONTROL, IT WAS REPORTED THAT BLOOD WAS GETTING EVERYWHERE DURING USE. THE LOT NUMBERS AND EXPIRATION DATES FOR THE ITEMS IN QUESTION ARE BELOW. PLEASE ADVISE ON HOW TO PROCEED. NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED ADDITIONAL INFORMATION 4/20/2026: 04-08-2026 AND AGAIN ON 04-11-2026 NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020111 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE DID NOT WORK. A CUSTOMER REACHED OUT TO LET US KNOW THAT ITEMS 382537 AND 382523 ARE HAVING ISSUES WITH BLOOD CONTROL. ALTHOUGH BOTH ITEMS ARE LABELED AS BLOOD CONTROL, IT WAS REPORTED THAT BLOOD WAS GETTING EVERYWHERE DURING USE. THE LOT NUMBERS AND EXPIRATION DATES FOR THE ITEMS IN QUESTION ARE BELOW. PLEASE ADVISE ON HOW TO PROCEED. NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000935 ↗
• MalfunctionFeb 25, 2026Retraction Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24446095 ↗
• MalfunctionFeb 25, 2026Retraction Problem

  THE CATHETER AND NEEDLE WERE INSIDE THE PATIENT AND THE NEEDLE RETRACTED ON ITS OWN AND THEN ONCE THE BUTTON WAS CLICKED TO RETRACT THE NEEDLE IT WAS EXTREMELY SLOW.

  Patient problems: Insufficient Information

  MAUDE report 24446086 ↗
• MalfunctionFeb 23, 2026Retraction Problem

  IT WAS REPORTED THAT "I TESTED ANOTHER CATHETER FROM THE SAME LOT AND RETRACTED SLOWLY AS WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417535 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Product Quality Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414380 ↗
• MalfunctionSep 4, 2025Material Integrity Problem; Material Integrity Problem

  "NEEDLE USED TO START IV IS GOING THROUGH THE PLASTIC CATHETER. THIS IS HAPPENING ON BOTH PRODUCT NUMBER LISTED AND HAS HAPPENED AT LEAST 4 TIMES IN THE PAST BUT BAD PRODUCT WAS DISPOSED." (B)(6) 2025: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025 THIS IS THE DATE REPORTED, NOT SURE OF THE OTHER DATES NOTED IN THE PAST. 2. IT WAS MENTIONED AS "HAPPENED AT LEAST 4 TIMES IN THE PAST" WAS IT OCCURRED ON SAME DATE WITH SAME MATERIAL # AND LOT#? KINDLY PROVIDE INFORMATION. NOT AVAILABLE. 3. WHAT WAS THE IMPACT TO THE PATIENT? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974094 ↗
• MalfunctionMay 6, 2025Retraction Problem; Retraction Problem

  MATERIAL#: 382537. BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE ISSUES WITH 18GA 382544 AND 20GA 382537 CATHS RETRACTING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OUR CLINICAL CUSTOMERS ARE REPORTING THAT THERE ARE ISSUES WITH 18GA 382544 AND 20GA 382537 CATHS RETRACTING. WE ARE PROVIDING PICTURE OF THE 18GA PACKAGING FOR ONE OF THESE CATHS. WE ARE UNSURE IF THIS ISSUE IS SPECIFIC TO CERTAIN LOT #¿S, OR WIDER SPREAD; TO GAIN BETTER UNDERSTANDING WE HAVE ASKED OUR CLINICAL PARTNERS TO PROVIDE PHYSICAL EXAMPLES OF THE PRODUCT, SO WE HAVE A BETTER UNDERSTANDING IF THIS IS A MORE WIDESPREAD ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970322 ↗
• MalfunctionMay 15, 2024Crack; Crack

  IT WAS REPORTED THAT BD INSYTE AUTOG BC CATHETER AND HUB IS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED IV AND FOUND CRACKED HUB AND CATHETER AFTER INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 19325789 ↗
• InjuryMar 12, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18887893 ↗
• MalfunctionOct 1, 2022Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BUTTON WILL NOT RETRACT THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522772 ↗
• MalfunctionAug 9, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT WHEN THE BUTTON WAS PRESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAD AN IV CATHETER NEEDLE NOT RETRACT EVEN AFTER PUSHING THE BUTTON MULTIPLE TIMES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294634 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Retraction Problem; Fluid/Blood Leak; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY NEEDLE GOT "STUCK" ON THE VALVE AND WOULD NOT RETRACT, LEAKING OUT BLOOD AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAS IT BEEN REPORTED TO YOU THAT THE US IV WILL NOT RETRACT?? IT GETS STUCK ON VALVE AND WHEN WE CAN GET IT LOOSE, THEN THERE IS BLOOD EVERYWHERE. WE HAVE HAD THIS HAPPEN SEVERAL TIMES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140283 ↗
• MalfunctionMay 27, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WILL NOT RETRACT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895109 ↗
• MalfunctionJan 28, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE INSYTE AUTOG BC PNK 20GA X 1.88IN NEEDLE WOULD NOT RETRACT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INSERTING THE IV PICC NURSE WAS UNABLE TO RETRACT THE NEEDLE FROM PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11248868 ↗
• MalfunctionMay 2, 2019Break

  IT WAS REPORTED THAT TWO 20G X 1.88IN (1.1 X 48 MM) INSYTE AUTOGUARD BC EXPERIENCED CANNULA BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382537, BATCH NO: UNKNOWN. PER CUSTOMER EMAIL: I WAS USING THIS CATHETER TO PLACE AN ULTRASOUND GUIDED IV LAST WEEK AND THIS LITTLE PLASTIC PIECE BECAME STUCK IN THE BASE OF THE LUER LOCK HUB OF THE CATHETER. IT APPEARS TO BE PART OF THE RETRACTING MECHANISM. I TRIED AGAIN WITH A SECOND ¿BD INSYTE AUTOGARD BC¿ AND THE PROBLEM HAPPENED AGAIN. I HAVE USED THIS SAME TYPE OF IV CATHETER MANY, MANY TIMES BEFORE AND NEVER SEEN THIS ISSUE BEFORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575948 ↗
• MalfunctionApr 2, 2019Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE OF A BD¿ INSYTE AUTOGUARD BC WAS RETRACTED ABOUT AN HOUR AFTER ACTIVATING SAFETY MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE PRODUCT DID NOT RETRACT, BUT THEN IT RETRACTED AFTER ABOUT AN HOUR (IT WAS JUST SITTING THERE AND RETRACTED ON ITS OWN) IT LOOKS LIKE THERE MAY BE SOME WARPING ON THE PLASTIC NEXT TO THE SPRING".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474516 ↗

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-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-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-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-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-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-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-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