BD Insyte-WRecalls & reported problems across all models
Becton, Dickinson And Company · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 249
- Deaths reported
- 1
- Injuries reported
- 16
- Recalls
- 0
We found 8 models of BD Insyte-W by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 249 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 23, 2026 — classified as 1 death, 16 injuries, 232 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (86 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
Reports received per month, all models
Most reported BD Insyte-W problems
Device problems
- Leak/Splash86
- Device Contamination with Chemical or Other Material41
- Break36
- Material Puncture/Hole16
- Defective Component14
- Material Split, Cut or Torn8
- Adverse Event Without Identified Device or Use Problem7
- Contamination /Decontamination Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- No Known Impact Or Consequence To Patient74
- No Consequences Or Impact To Patient19
- No Patient Involvement8
- Extravasation5
- Insufficient Information5
- Erythema4
- Foreign Body In Patient4
BD Insyte-W models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Insyte-W 381312Catheter,intravascular,therapeutic,short-term less than 30 days1 death161 reports
- BD Insyte-W 381323Catheter,intravascular,therapeutic,short-term less than 30 days46 reports
- BD Insyte-W 381334Catheter,intravascular,therapeutic,short-term less than 30 days19 reports
- BD Insyte-W 381337Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- BD Insyte-W 381333Catheter,intravascular,therapeutic,short-term less than 30 days5 reports
- BD Insyte-W 381347Catheter,intravascular,therapeutic,short-term less than 30 days5 reports
- BD Insyte-W 381344Catheter,intravascular,therapeutic,short-term less than 30 days4 reports
- BD Insyte-W 381357Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
Recent BD Insyte-W adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873051 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873036 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873035 ↗MalfunctionSep 11, 2026Fluid/Blood Leak; Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736903 ↗MalfunctionSep 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736902 ↗MalfunctionSep 8, 2026Leak/Splash; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674224 ↗MalfunctionJun 12, 2026Material Perforation
IT WAS REPORTED BY CUSTOMER THAT STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. OBSERVED ISSUE PLEASE PROVIDE A DESCRIPTION OF THE OBSERVED ISSUE: STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. CUSTOMER RESPONSE ON 01-JUN-2026. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? - THIS HAS BEEN AN ONGOING ISSUE WITH THIS LOT NUMBER. DATE I HAVE PHOTOS FROM IS 05-21-2026 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. - COMPLICATION IS THE CATHETERS SEEM STICKY, WE CAN¿T ADVANCE THE CATHETER EASILY AND THE STYLET IS PIERCING THROUGH THE FLEXIBLE CATHETER 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? - I HAVE 2 FULL BOXES (100) PLUS AN OPEN BOX OF CATHETERS WITH THE SAME LOT NUMBERS THAT WE¿VE BEEN STRUGGLING WITH XXX".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488445 ↗MalfunctionJun 12, 2026Material Perforation
IT WAS REPORTED BY CUSTOMER THAT STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. OBSERVED ISSUE: PLEASE PROVIDE A DESCRIPTION OF THE OBSERVED ISSUE: STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. CUSTOMER RESPONSE ON 01-JUN-2026. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? THIS HAS BEEN AN ONGOING ISSUE WITH THIS LOT NUMBER. DATE I HAVE PHOTOS FROM (B)(6) 2026. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. - COMPLICATION IS THE CATHETERS SEEM STICKY, WE CAN¿T ADVANCE THE CATHETER EASILY AND THE STYLET IS PIERCING THROUGH THE FLEXIBLE CATHETER. 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? - I HAVE 2 FULL BOXES (100) PLUS AN OPEN BOX OF CATHETERS WITH THE SAME LOT NUMBERS THAT WE¿VE BEEN STRUGGLING WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488441 ↗MalfunctionJun 11, 2026Leak/Splash
THEY TELL US THAT THE CATHETER CONNECTION (THREADED JOINT) DOES NOT SEEM TO BE PROPERLY SECURED AND IS LEAKING SALINE. BATCH: 5337999 OF 1. WE HAVE A CUSTOMER WHO HAS INFORMED US THAT THE LATEST BOX THEY RECEIVED OF INSYTE W ALETAS 24G YELLOW - REF. 381312 IS CAUSING THEM PROBLEMS. THIS CUSTOMER HAS BEEN PURCHASING THE PRODUCT REGULARLY SINCE 2020 AND HAD NEVER COMPLAINED BEFORE. THEY TELL US THAT THE CATHETER CONNECTION (THREAD) DOES NOT SEEM TO FIT PROPERLY AND IS LEAKING SALINE. BATCH: 5337999, DATED 30/11. WHEN DID THE INCIDENT OCCUR? BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473306 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
AT 9:10 A.M. ON (B)(6) 2026, WHILE PERFORMING AN INTRAVENOUS PUNCTURE ON A PATIENT, THE NEEDLE CONE DAMAGED THE TUBING AS SOON AS THE CANNULA ENTERED THE VEIN, MAKING IT IMPOSSIBLE TO ADVANCE THE CATHETER INTO THE VEIN. THE EQUIPMENT WAS REPLACED IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334274 ↗MalfunctionMay 21, 2026Nonstandard Device
(B)(6) 2026: WHILE INSERTING AN IV CANNULA INTO A PATIENT, A NURSE DISCOVERED THAT THE CANNULA SHEATH COULD NOT BE REMOVED. THE CANNULA WAS REPLACED, AND THE ADVERSE EVENT WAS DOCUMENTED AND REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243839 ↗MalfunctionMay 12, 2026Nonstandard Device
NURSE REPORTED TUBING BREAKAGE DURING USE, NUMBER OF UNITS AFFECTED 10, PHYSICAL DEVICE CAN BE RETURNED 1, PHOTOGRAPHS AVAILABLE, GREEN CLAIM REQUIRED, COMPLAINT RETURN LETTER REQUIRED, COMPLAINT RECEIPT LETTER REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150367 ↗MalfunctionMay 1, 2026Fluid/Blood Leak
DURING USE, FLUID LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER ADAPTER. ONE UNIT WAS DEFECTIVE; THE DEFECTIVE PRODUCT WAS NOT RETURNED, BUT VIDEO EVIDENCE IS AVAILABLE. NO CLAIM IS REQUIRED; HOWEVER, A RESPONSE LETTER TO THE COMPLAINT AND A RECEIPT OF COMPLAINT ARE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057254 ↗MalfunctionApr 13, 2026Leak/Splash
IT WAS REPORTED THAT WE NOTICE A PROBLEM WITH THE BD INSYTE-W WITH LOT 5204426 CATHETER NEEDLES. THE TRANSITION BETWEEN CATHETER AND CONNECTION IS LEAKING. THIS HAS BEEN NOTICED BY SEVERAL NURSES. WE ARE GOING TO TRY TO KEEP TRACK OF DEFECTIVE CATHETERS. OUR PEDIATRICS DEPARTMENT HAS ESTABLISHED THAT THE BD INSYTE-W 24G X 19MM (REF 381312) IS A QUALITY ISSUE IN LOT 5204426. IS THIS SOMETHING YOU HAVE ALREADY HEARD FROM OTHERS?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861506 ↗MalfunctionMar 9, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, AT 9:50 AM, DURING A VENIPUNCTURE PROCEDURE ON THE PATIENT, THE NEEDLE CORE DISLODGED MID-PROCEDURE. THE NEEDLE CORE STALLED DURING INSERTION, AND RESISTANCE WAS ENCOUNTERED UPON ENTERING THE VESSEL. TWO SUBSEQUENT ATTEMPTS USING NEEDLES OF THE SAME BRAND WERE UNSUCCESSFUL. A DIFFERENT BRAND OF INDWELLING NEEDLE WAS THEN USED, RESULTING IN A SUCCESSFUL PUNCTURE.
Patient problems: Discomfort
MAUDE report 24551638 ↗
Other Becton, Dickinson And Company products
- BD Vacutainer SST10 models · 4,985 reports · 3 recalls
- BD Luer-Lok48 models · 5,117 reports
- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page