BD NexivaRecalls & reported problems across all models
Becton, Dickinson And Company · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BD Nexiva model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,614
- Deaths reported
- 1
- Injuries reported
- 34
- Recalls
- 1
We found 25 models of BD Nexiva by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,614 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2017 and Sep 30, 2026 — classified as 1 death, 34 injuries, 1,579 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (506 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
BD Nexiva recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 12, 2022Open, Classified
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Z-0174-2023 · Root cause: Storage · Recall details · FDA record ↗
Most reported BD Nexiva problems
Device problems
- Leak/Splash506
- Fluid/Blood Leak187
- Difficult or Delayed Activation97
- Device Contamination with Chemical or Other Material87
- Retraction Problem82
- Break79
- Material Puncture/Hole66
- Material Separation64
Patient problems
- No Clinical Signs, Symptoms or Conditions1,032
- No Known Impact Or Consequence To Patient291
- No Consequences Or Impact To Patient90
- Insufficient Information82
- No Patient Involvement25
- Pain17
- Hemorrhage/Blood Loss/Bleeding13
- No Information10
BD Nexiva models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Nexiva 383516Catheter,intravascular,therapeutic,short-term less than 30 days1 recall294 reports
- BD Nexiva 383512Catheter,intravascular,therapeutic,short-term less than 30 days295 reports
- BD Nexiva 383517Catheter,intravascular,therapeutic,short-term less than 30 days223 reports
- BD Nexiva 383511Catheter,intravascular,therapeutic,short-term less than 30 days186 reports
- BD Nexiva 383519Catheter,intravascular,therapeutic,short-term less than 30 days151 reports
- BD Nexiva 383556Catheter,intravascular,therapeutic,short-term less than 30 days103 reports
- BD Nexiva 383557Catheter,intravascular,therapeutic,short-term less than 30 days90 reports
- BD Nexiva 383552Catheter,intravascular,therapeutic,short-term less than 30 days84 reports
- BD Nexiva 383559Catheter,intravascular,therapeutic,short-term less than 30 days54 reports
- BD Nexiva 383551Catheter,intravascular,therapeutic,short-term less than 30 days1 death33 reports
- BD Nexiva 383518Catheter,intravascular,therapeutic,short-term less than 30 days24 reports
- BD Nexiva 383510Catheter,intravascular,therapeutic,short-term less than 30 days15 reports
- BD Nexiva 383520Catheter,intravascular,therapeutic,short-term less than 30 days11 reports
- BD Nexiva 383558Catheter,intravascular,therapeutic,short-term less than 30 days11 reports
- BD Nexiva 383576Catheter, intravascular, therapeutic, short-term less than 30 days11 reports
- BD Nexiva 383572Catheter, intravascular, therapeutic, short-term less than 30 days7 reports
- BD Nexiva 383550Set, administration, intravascular5 reports
- BD Nexiva 383513Catheter,intravascular,therapeutic,short-term less than 30 days4 reports
- BD Nexiva 383579Catheter, intravascular, therapeutic, short-term less than 30 days4 reports
- BD Nexiva 383545Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- BD Nexiva 383571Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- BD Nexiva 383577Catheter, intravascular, therapeutic, short-term less than 30 days2 reports
- BD Nexiva 383541Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- BD Nexiva 383553Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- BD Nexiva 383560Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Recent BD Nexiva adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954903 ↗MalfunctionSep 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952603 ↗MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935971 ↗MalfunctionSep 29, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932697 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921289 ↗MalfunctionSep 24, 2026Material Puncture/Hole
It was reported that BD NEXIVA needle pierced the catheter. The catheter kinked while in situ in the patient, resulting in catheter occlusion. Additional information 18 Sep 2026: No Patient harm of user harm is known to have occurred.Based on the images received, it appears that the needle may have been partially withdrawn during catheter insertion and subsequently advanced again. As a result, it is possible that the catheter was punctured by the needle. I also wonder whether the user is familiar with Instaflash and its intended use during insertion.I have offered additional training and clinical support to the involved department to review device use and help prevent similar events in the future. Emma indicated that se would like to make use of this training opportunity.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884816 ↗MalfunctionSep 24, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884807 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884802 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875123 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874629 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874627 ↗MalfunctionSep 23, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873048 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779958 ↗MalfunctionSep 15, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50779955 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779953 ↗
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 BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
- BD Vacutainer UltraTouch Push Button Blood Collection Set6 models · 1,468 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.
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