ULTRASITERecalls & reported problems across all models

We found 12 models of ULTRASITE by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Jun 9, 2026 — classified as 112 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (51 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

ULTRASITE 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. Sep 15, 2022Open, Classified

   The extension set has a high probability of 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-0090-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported ULTRASITE problems

ULTRASITE models

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

• ULTRASITE® 474515

  Set, administration, intravascular
  1 recall0 reports
• ULTRASITE® 473438

  Set, administration, intravascular
  48 reports
• ULTRASITE® 415110

  Set, administration, intravascular
  17 reports
• ULTRASITE® US1921

  Set, administration, intravascular
  15 reports
• ULTRASITE® 473444

  Set, administration, intravascular
  6 reports
• ULTRASITE® 470021

  Set, administration, intravascular
  5 reports
• ULTRASITE® 473447

  Set, administration, intravascular
  5 reports
• ULTRASITE® 474921

  Set, administration, intravascular
  5 reports
• ULTRASITE® 473443

  Set, administration, intravascular
  4 reports
• ULTRASITE® 473448

  Set, administration, intravascular
  3 reports
• ULTRASITE® 473992

  Set, administration, intravascular
  3 reports
• ULTRASITE® 375100

  Set, administration, intravascular
  1 report

Recent ULTRASITE adverse event reports

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

• MalfunctionJun 9, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: WHILE IV CONTRAST WAS BEING ADMINISTERED, BRAUN IV TUBE CAP CAME OFF THE IV TUBING. BLOOD AND IV CONTRAST SPILLED ONTO FLOOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25449963 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WHEN ATTACHING THE ULTRASITE TO THE IV CATHETER AND SECURE IT, BLOOD STARTS POURING OUT OF THE SITE. SO, ULTIMATELY IT IS NOT GETTING A GOOD SEAL. THEY ALL LOOK THE SAME AND WE ARE UNABLE TO TELL IF IT IS OK UNTIL WE TRY TO LOCK IT INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645334 ↗
• MalfunctionMar 16, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION SUMMARY: RN WAS FLUSHING PATIENT'S CAP (B BRAUN ULTRASITE INJECTION SITE CAP REF: 415110 LOT#0061960991) AND BLOOD WAS LEAKING OUT AT THE CONNECTION WHERE IT SHOULDN'T BE LEAKING OUT OF. ALL CAPS FROM SAME LOT# PULLED. VERIFIED LOT 0061966510 GOES WITH 490102. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615364 ↗
• MalfunctionMar 15, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE PRODUCT KEEPS BREAKING AND THE PATIENTS ARE SPEWING BLOOD EVERYWHERE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613674 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THERE SEEMS TO BE AN EXTRA PIECE OF PLASTIC ATTACHED AND WHEN YOU USE IT BLOOD COME OUT OF THE PLASTIC ATTACHMENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344167 ↗
• MalfunctionJan 31, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING AT CONNECTION POINT BETWEEN ULTRASITE AND IVC. DETAILED INQUIRY DESCRIPTION: WHEN ATTACHING THE ULTRASITE TO THE IV CATHETER AND SECURE IT, BLOOD STARTS POURING OUT OF THE SITE. SO, ULTIMATELY IT IS NOT GETTING A GOOD SEAL. THEY ALL LOOK THE SAME AND WE ARE UNABLE TO TELL IF IT IS OK UNTIL WE TRY TO LOCK IT INTO THE CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21286726 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.

  Patient problems: Chemical Exposure

  MAUDE report 20398503 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  AS REPORTED, EVENT 1 THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.

  Patient problems: Chemical Exposure

  MAUDE report 20398448 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  AS REPORTED, EVENT 4: THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.

  Patient problems: Chemical Exposure

  MAUDE report 20398395 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.

  Patient problems: Chemical Exposure

  MAUDE report 20398381 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE ULTRASITE AND EXT SET CONNECTION. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A HANDFUL OF 6.5" EXTENSION SETS RECENTLY THAT ARE LEAKING AND EVEN COMING COMPLETELY APART BETWEEN THE WHITE ULTRASITE INJECTION PORT AND THE DISTAL LUER-LOCK END OF THE TUBING. THIS LEADS TO BACK FLOW OF BLOOD FROM THE IV CATHETER AND POTENTIAL INFECTION RISK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766565 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE ULTRASITE AND EXT SET CONNECTION. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A HANDFUL OF 6.5" EXTENSION SETS RECENTLY THAT ARE LEAKING AND EVEN COMING COMPLETELY APART BETWEEN THE WHITE ULTRASITE INJECTION PORT AND THE DISTAL LUER-LOCK END OF THE TUBING. THIS LEADS TO BACK FLOW OF BLOOD FROM THE IV CATHETER AND POTENTIAL INFECTION RISK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766564 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE ULTRASITE AND EXT SET CONNECTION. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A HANDFUL OF 6.5" EXTENSION SETS RECENTLY THAT ARE LEAKING AND EVEN COMING COMPLETELY APART BETWEEN THE WHITE ULTRASITE INJECTION PORT AND THE DISTAL LUER-LOCK END OF THE TUBING. THIS LEADS TO BACK FLOW OF BLOOD FROM THE IV CATHETER AND POTENTIAL INFECTION RISK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766562 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 5: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE ULTRASITE AND EXT SET CONNECTION. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A HANDFUL OF 6.5" EXTENSION SETS RECENTLY THAT ARE LEAKING AND EVEN COMING COMPLETELY APART BETWEEN THE WHITE ULTRASITE INJECTION PORT AND THE DISTAL LUER-LOCK END OF THE TUBING. THIS LEADS TO BACK FLOW OF BLOOD FROM THE IV CATHETER AND POTENTIAL INFECTION RISK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766560 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE ULTRASITE AND EXT SET CONNECTION. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A HANDFUL OF 6.5" EXTENSION SETS RECENTLY THAT ARE LEAKING AND EVEN COMING COMPLETELY APART BETWEEN THE WHITE ULTRASITE INJECTION PORT AND THE DISTAL LUER-LOCK END OF THE TUBING. THIS LEADS TO BACK FLOW OF BLOOD FROM THE IV CATHETER AND POTENTIAL INFECTION RISK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766559 ↗

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