BD InsyteRecalls & reported problems across all models

We found 10 models of BD Insyte by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 259 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Jun 3, 2026 — classified as 22 injuries, 237 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (70 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BD Insyte problems

BD Insyte models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Insyte 381223

  Catheter,intravascular,therapeutic,short-term less than 30 days
  73 reports
• BD Insyte 381212

  Catheter,intravascular,therapeutic,short-term less than 30 days
  71 reports
• BD Insyte 381237

  Catheter,intravascular,therapeutic,short-term less than 30 days
  44 reports
• BD Insyte 381234

  Catheter,intravascular,therapeutic,short-term less than 30 days
  27 reports
• BD Insyte 381244

  Catheter,intravascular,therapeutic,short-term less than 30 days
  16 reports
• BD Insyte 381247

  Catheter,intravascular,therapeutic,short-term less than 30 days
  9 reports
• BD Insyte 381254

  Catheter,intravascular,therapeutic,short-term less than 30 days
  8 reports
• BD Insyte 381233

  Catheter,intravascular,therapeutic,short-term less than 30 days
  6 reports
• BD Insyte 381267

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• BD Insyte 381257

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports

Recent BD Insyte adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Nonstandard Device

  "IT WAS REPORTED THAT INTRAVENOUS CATHETER 20G VIALON 381234 LOT 4177835 FV 30/06/2029, WHICH ACCORDING TO THE REPORT ¿WHEN THE PATIENT IS PUNCTURED, THE CHAMBER IS NOT FULL AND WHEN IT IS RETRACTED, THE CATHETER IS DAMAGED AND MANY TIMES THE CORE DOES NOT PIERCE THE SKIN, BESIDES THEY ARE ALMOST BLUNT¿. MEDICAL DEVICE AVAILABLE FOR EVALUATION? YES, HAS THE DEVICE BEEN USED MORE THAN ONCE? YES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25378248 ↗
• MalfunctionMar 31, 2026Separation Problem

  IT WAS REPORTED THAT THE CATHETER CAME OFF THE NEEDLE DURING IV INSERTION. IT WAS REPORTED THAT MULTIPLE IV ATTEMPTS AS THE JELCOS PLASTIC CANNULA "FALLS OFF " THE NEEDLES AND TRYING TO ATTEMPT TO ADVANCE THE CANNULA, THE CANULA BENDS AND DOES NOT WORK PROPERLY. ADDITIONAL INFORMATION 3/24/2026: WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? IN PATIENT. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? NO. COULD YOU PLEASE PROVIDE A DATE OF EVENT? (B)(6) 2026. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. END USER COULD NOT CONFIRM AS THE COMPLAINT WAS FOR ALL WARDS AND THEATRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741652 ↗
• MalfunctionMar 31, 2026Separation Problem

  IT WAS REPORTED THAT THE CATHETER CAME OFF THE NEEDLE DURING IV INSERTION. IT WAS REPORTED THAT MULTIPLE IV ATTEMPTS AS THE JELCOS PLASTIC CANNULA "FALLS OFF " THE NEEDLES AND TRYING TO ATTEMPT TO ADVANCE THE CANNULA, THE CANULA BENDS AND DOES NOT WORK PROPERLY. ADDITIONAL INFORMATION 3/24/2026: WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? IN PATIENT. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? NO. COULD YOU PLEASE PROVIDE A DATE OF EVENT? 17 FEBRUARY 2026. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. END USER COULD NOT CONFIRM AS THE COMPLAINT WAS FOR ALL WARDS AND THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741650 ↗
• MalfunctionMar 25, 2026Nonstandard Device

  THE SECAE FIXATOR IS NOT SUPPOSED TO HAVE ANY FIXATION WITH RESPECT TO THE CATHETER. DURING USE IT WAS REPORTED THAT, RECENTLY SUPPLIED VENOUS CANNULATION CATHETERS HAVE BEEN FOUND TO HAVE A DEFECT THAT COMPROMISES THE SAFETY OF THE PROCEDURE. A DEFECT THAT COMPROMISES THE SAFETY OF THE PROCEDURE. THE CLAMP DOES NOT REMAIN FIRMLY DURING CANNULATION, CAUSING THE CATHETER TO DETACH UNEXPECTEDLY FROM THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 24688544 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT THE PATIENT HAD A CANNULATED VENOUS ACCESS SINCE THE PREVIOUS DAY; DURING THE ADMINISTRATION OF THERAPY, THE INFUSION PUMP ALARM WAS ACTIVATED AND, ON ASSESSING AND REMOVING THE DEVICE, A CATHETER FRACTURE WAS OBSERVED. IN ADDITION, SIGNS OF PHLEBITIS (ERYTHEMA AND LOCAL PAIN) WERE OBSERVED AT THE PUNCTURE SITE, WITH NO EVIDENCE OF FRAGMENT RETENTION OR OTHER IMMEDIATE COMPLICATIONS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24568794 ↗
• MalfunctionMar 10, 2026Break

  "DURING THE PERIPHERAL VENOUS CANNULATION PROCEDURE WITH INTRAVENOUS CATHETER, AT THE TIME OF INSERTION AND MANIPULATION OF THE DEVICE, A FRACTURE OF THE CATHETER BEVEL WAS EVIDENCED. THE PROCEDURE WAS IMMEDIATELY SUSPENDED, VERIFYING THE INTEGRITY OF THE DEVICE AND THE STATE OF THE PUNCTURE SITE. THE PATIENT WAS ASSESSED AND THERE WAS NO EVIDENCE OF IMMEDIATE COMPLICATIONS, SUCH AS ACTIVE BLEEDING, SEVERE PAIN OR SIGNS OF FRAGMENT RETENTION. SUBSEQUENTLY, THE DEVICE WAS DISCARDED ACCORDING TO INSTITUTIONAL PROTOCOL AND A NEW CANNULATION WAS PERFORMED WITH STERILE MATERIAL, WITH NO NEW DEVELOPMENTS. THE EVENT WAS REPORTED FOR FOLLOW-UP AND QUALITY CONTROL OF THE MEDICAL DEVICE. ADDITIONAL INFORMATION RECEIVED ON 26-FEB-2026 EMAIL FOLLOW UP: COULD YOU PLEASE CONFIRM HOW MANY UNITS OF THE PRODUCT PRESENTED THE ISSUE/DEFECT? IN RESPONSE TO YOUR COMMUNICATION REGARDING CLAIM NO. (B)(4), WE INFORM YOU THAT TWO (2) UNITS OF THE PRODUCT WITH THE REPORTED PROBLEM HAVE BEEN SUBMITTED. COULD YOU PROVIDE PHOTOS AND/OR VIDEOS OF THE PRODUCT SHOWING THE DEFECT? REGARDING THE EVIDENCE, IN THE FIRST CASE, THERE IS PHOTOGRAPHIC EVIDENCE, WHICH HAS ALREADY BEEN SENT FOR REVIEW. IN THE SECOND CASE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563587 ↗
• MalfunctionMar 10, 2026Break

  "DURING THE PERIPHERAL VENOUS CANNULATION PROCEDURE WITH INTRAVENOUS CATHETER, AT THE TIME OF INSERTION AND MANIPULATION OF THE DEVICE, A FRACTURE OF THE CATHETER BEVEL WAS EVIDENCED. THE PROCEDURE WAS IMMEDIATELY SUSPENDED, VERIFYING THE INTEGRITY OF THE DEVICE AND THE STATE OF THE PUNCTURE SITE. THE PATIENT WAS ASSESSED AND THERE WAS NO EVIDENCE OF IMMEDIATE COMPLICATIONS, SUCH AS ACTIVE BLEEDING, SEVERE PAIN OR SIGNS OF FRAGMENT RETENTION. SUBSEQUENTLY, THE DEVICE WAS DISCARDED ACCORDING TO INSTITUTIONAL PROTOCOL AND A NEW CANNULATION WAS PERFORMED WITH STERILE MATERIAL, WITH NO NEW DEVELOPMENTS. THE EVENT WAS REPORTED FOR FOLLOW-UP AND QUALITY CONTROL OF THE MEDICAL DEVICE. ADDITIONAL INFORMATION RECEIVED ON 26-FEB-2026. EMAIL FOLLOW UP: COULD YOU PLEASE CONFIRM HOW MANY UNITS OF THE PRODUCT PRESENTED THE ISSUE/DEFECT? IN RESPONSE TO YOUR COMMUNICATION REGARDING CLAIM NO. (B)(4), WE INFORM YOU THAT TWO (2) UNITS OF THE PRODUCT WITH THE REPORTED PROBLEM HAVE BEEN SUBMITTED. COULD YOU PROVIDE PHOTOS AND/OR VIDEOS OF THE PRODUCT SHOWING THE DEFECT? REGARDING THE EVIDENCE, IN THE FIRST CASE, THERE IS PHOTOGRAPHIC EVIDENCE, WHICH HAS ALREADY BEEN SENT FOR REVIEW. IN THE SECOND CASE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563582 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING THE CANNULATION PROCEDURE, THE DEVICE FAILED WHEN IT BROKE IN HALF, PREVENTING IT FROM FUNCTIONING PROPERLY. AS A RESULT, IT HAD TO BE DISCARDED AND REPLACED, REQUIRING THE PATIENT TO BE REPROCESSED. BATCH: 5116410 REF: 381244 IT IS NOTED THAT THE EMERGENCY DEPARTMENT HAS PREVIOUSLY REPORTED DISSATISFACTION WITH THIS PRODUCT. THE REPORT WAS RECEIVED ON JANUARY 29. ADDITIONAL INFORMATION RECEIVED ON 12 FEB 2026 QUANTITIES AFFECTED: ONE (1) UNIT OF THE 18G PERIPHERAL IV CATHETER (CS10-72700302), LOT 5116410, IS CONFIRMED AS AFFECTED. EVIDENCE (PHOTO/VIDEO): A PHOTOGRAPHIC RECORD OF THE DEVICE PACKAGING IS ATTACHED. THERE IS NO IMAGE OF THE DEVICE IN USE. DAMAGE TO PATIENT HEALTH: THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. THE EVENT WAS IDENTIFIED DURING THE PROCEDURE AND THE DEVICE WAS REPLACED TO CONTINUE CARE. AVAILABILITY OF SAMPLE FOR ANALYSIS: THE SAMPLE IS NOT AVAILABLE BECAUSE THE DEVICE CAME INTO CONTACT WITH THE PATIENT AND WAS DISCARDED IN ACCORDANCE WITH INSTITUTIONAL BIOSAFETY PROTOCOLS. HOWEVER, THE PRODUCT PACKAGING IS RETAINED AND PROVIDED AS EVIDENCE OF THE EVENT. INFORMATION FOR COLLECTION AND REPLACEMENT: SINCE THE DEVICE WAS DISCARDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433219 ↗
• InjuryFeb 10, 2026Break; Material Separation

  DURING ARTERIAL CATHETER INSERTION, THERE WAS NO BLOOD RETURN. UPON WITHDRAWING THE SOFT CATHETER, APPROXIMATELY 2 CM WAS FOUND BROKEN AND RETAINED IN THE BODY. THE LIKELY CAUSE WAS THE PATIENT¿S AGITATION AND FORCEFUL TWISTING DURING THE PROCEDURE, WHICH LED TO CATHETER BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24305934 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  IT WAS REPORTED THAT, DURING INJECTIONS OF CONTRAST MEDIUM FOR CT SCANS, LEAKAGE AT THE LUER CONNECTION BETWEEN THE CATHETER AND THE EXTENSION PIECE (PVC 75CM ROBINET 3V REF PS3307M CAR) ARE OBSERVED. THE INCIDENT OCCURRED SEVERAL TIMES, FOR THE SAME BATCH OF CATHETERS. NO LEAKAGE WAS OBSERVED WITH ANOTHER BATCH OF CATHETERS AND THE SAME EXTENSIONS. CLINICAL CONSEQUENCES - UNABLE TO INJECT CONTRAST MEDIUM. NEED TO INSERT ANOTHER PERIPHERAL VENOUS LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235737 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  IT WAS REPORTED THAT, DURING INJECTIONS OF CONTRAST MEDIUM FOR CT SCANS, LEAKAGE AT THE LUER CONNECTION BETWEEN THE CATHETER AND THE EXTENSION PIECE (PVC 75CM ROBINET 3V REF PS3307M CAR) ARE OBSERVED. THE INCIDENT OCCURRED SEVERAL TIMES, FOR THE SAME BATCH OF CATHETERS. NO LEAKAGE WAS OBSERVED WITH ANOTHER BATCH OF CATHETERS AND THE SAME EXTENSIONS. CLINICAL CONSEQUENCES - UNABLE TO INJECT CONTRAST MEDIUM. NEED TO INSERT ANOTHER PERIPHERAL VENOUS LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235716 ↗
• MalfunctionJan 7, 2026Leak/Splash

  IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN LEAKED ENTRY DESCRIPTION OF (B)(6): ON (B)(6) 2025, A NURSE DISCOVERED LEAKAGE AT THE CONNECTION POINT AFTER PRIMING A SYRINGE. APPROXIMATELY FIVE SYRINGES OF THIS MODEL WERE FOUND TO BE DEFECTIVE IN THE BOX. DURING USE OF THIS PRODUCT, LOOSE CONNECTIONS CAUSED LEAKAGE; ONE UNIT AFFECTED; SAMPLE CAN BE RETURNED WITH PHOTOS PROVIDED; REQUIRES GREEN CLAIMS PROCESSING; REQUIRES COMPLAINT RESPONSE LETTER; REQUIRES COMPLAINT RECEIPT LETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999509 ↗
• MalfunctionJan 6, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 23983302 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER PLACEMENT IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT, AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: 25/11/2025, AS PER CLIENT, WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. THERE WAS NO INDICATION OF A POTENTIAL PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768645 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER PLACEMENT IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT, AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: (B)(6) 2025 AS PER CLIENT, WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. THERE WAS NO INDICATION OF A POTENTIAL PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768636 ↗

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