CaresiteRecalls & reported problems across all models

We found 23 models of Caresite by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 420 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 25, 2026 — classified as 1 death, 1 injury, 418 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (219 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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

Caresite 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.

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0626-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0625-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

3. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0624-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

4. Sep 15, 2022Open, Classified

   The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

   Z-0092-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported Caresite problems

Caresite models

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

• Caresite® 415122

  Set, administration, intravascular
  1 death152 reports
• Caresite® 354205

  Set, administration, intravascular
  1 recall17 reports
• Caresite® 354207

  Set, administration, intravascular
  1 recall13 reports
• Caresite® 354221

  Set, administration, intravascular
  59 reports
• Caresite® 354203

  Set, administration, intravascular
  1 recall8 reports
• Caresite® 354202

  Set, administration, intravascular
  1 recall1 report
• Caresite® 354204

  Set, administration, intravascular
  1 recall1 report
• Caresite® 354206

  Set, administration, intravascular
  1 recall1 report
• Caresite® 470114

  Set, administration, intravascular
  1 recall0 reports
• Caresite® 470100

  Set, administration, intravascular
  46 reports
• Caresite® 470101

  Set, administration, intravascular
  44 reports
• Caresite® 354220

  Set, administration, intravascular
  26 reports
• Caresite® 470108

  Set, administration, intravascular
  10 reports
• Caresite® 470103

  Set, administration, intravascular
  9 reports
• Caresite® 470106

  Set, administration, intravascular
  8 reports
• Caresite® 470117

  Set, administration, intravascular
  6 reports
• Caresite® 470104

  Set, administration, intravascular
  5 reports
• Caresite® 470107

  Set, administration, intravascular
  5 reports
• Caresite® 470124

  Set, administration, intravascular
  3 reports
• Caresite® 470109

  Set, administration, intravascular
  2 reports
• Caresite® 470116

  Set, administration, intravascular
  2 reports
• Caresite® 354201

  Set, administration, intravascular
  1 report
• Caresite® 470105

  Set, administration, intravascular
  1 report

Recent Caresite adverse event reports

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

• MalfunctionSep 25, 2026Air/Gas in Device

  As reported by the user facility:End user reported air bubbles in the line, which is causing their machines to alert. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896573 ↗
• MalfunctionApr 22, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING CHEMO ADMINISTRATION THE FILTER LEAKED. THE NURSE REPORTS THAT ALL CONNECTIONS TO THE LINES AND BAG WERE SECURE AND THE LEAK WAS VISIBLY COMING FROM THE FILTER OF THE FILTERED EXTENSION SET. SHE VISUALLY INSPECTED, AND COULD NOT SEE ANY NOTICEABLE BREAKS IN THE PLASTIC OR FILTER AREA SO NOT ENTIRELY SURE HOW THIS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955548 ↗
• MalfunctionMar 31, 2026Crack; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CARESITE CRACKED AND LEAKED DURING A CHEMO INFUSION WHICH LED TO A CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741562 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713671 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713330 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713168 ↗
• MalfunctionMar 26, 2026Free or Unrestricted Flow

  AS REPORTED VIA MEDWATCH NUMBER MW5183916: ROLLER CLAMPS ON GRAVITY IV TUBING NOT STOPPING INFUSION OF ORDERED MEDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706060 ↗
• MalfunctionMar 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY. THE CARESITE LUER ACCESS DEVICE ATTACHED TO PATIENT'S PICC LINE NOTED TO BE LEAKING BLOOD AND IV FLUID. UPON INSPECTION AND FLUSHING WITH NORMAL SALINE SYRINGE, THE LEAK WAS ISOLATED TO THE LUER ACCESS DEVICE ITSELF. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24702540 ↗
• MalfunctionMar 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY. THE CARESITE LUER ACCESS DEVICE ATTACHED TO PATIENT'S PICC LINE NOTED TO BE LEAKING BLOOD AND IV FLUID. UPON INSPECTION AND FLUSHING WITH NORMAL SALINE SYRINGE, THE LEAK WAS ISOLATED TO THE LUER ACCESS DEVICE ITSELF. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24702539 ↗
• MalfunctionMar 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: CARESITE LUER ACCESS DEVICE ATTACHED TO PATIENT'S PICC LINE NOTED TO BE LEAKING BLOOD AND IV FLUID. UPON INSPECTION AND FLUSHING WITH NORMAL SALINE SYRINGE, THE LEAK WAS ISOLATED TO THE LUER ACCESS DEVICE ITSELF. NEW LUER ACCESS DEVICE PLACED, AND OLD DEVICE REMOVED FROM PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702534 ↗
• MalfunctionMar 18, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: A NURSE EMPLOYEE NOTICED A BROWN/BLACK SPEC INSIDE OF THE TUBING OF A NON-FILTERED IV TUBING THAT WAS SEALED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625922 ↗
• MalfunctionMar 12, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): SETS ARE LEAKING AND AIR IS GETTING INTO THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578418 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  PER MEDSUN NUMBER (B)(4): DESCRIBE THE EVENT OR PROBLEM: PATIENT PRESENTED TO INFUSION CENTER FOR CHEMO PUMP D/C [DISCONTINUATION]. UPON ASSESSMENT OF PORT SITE, WHITE DRIED POWDER LEAKING PRESENT ON RIGHT SIDE OF CHEST SKIN, PUMP STRAP AND PATIENT'S BRA AROUND CONNECTION SITE FROM PORT TUBING TO PUMP TUBING. RN EDUCATED PATIENT AND DAUGHTER THAT THIS IS A SIGN OF THE CHEMO LEAKING AND IF IN THE FUTURE ANY DRIED WHITE MATTER IS NOTED TO CALL AND BE SEEN IN INFUSION. PATIENTS SKIN WAS CLEANED WITH SOAP AND WATER AND PATIENT GIVEN A NEW SHIRT TO WEAR HOME. RN REINFORCED EDUCATION ABOUT HAZARDOUS MEDICATIONS AND SPILLS, PATIENT'S EXPOSED CLOTHES WERE BAGGED AND INSTRUCTIONS FOR WASHING TWICE SEPARATELY IN HOT WATER WAS REINFORCED. WHEN PATIENT CHANGED SHIRT, RASH TO CHEST, NECK, UPPER ABDOMEN AND BACK WAS NOTED, RN INSTRUCTED PATIENT TO REPORT THIS AND HAVE THIS SEEN BY PROVIDER AT APPOINTMENT THIS MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460665 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: END USER STATED THAT THERE IS VISIBLE MOLD/FOREIGN OBJECT INSIDE THE EXTENSION SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413197 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406314 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls