ADDitIVRecalls & reported problems across all models

We found 7 models of ADDitIV by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2022 and Apr 30, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

3 FDA recall records name at least one of these models by its device identifier, 3 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

ADDitIV 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-0605-2026 · 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-0604-2026 · Root cause: Process control · 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-0603-2026 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

Most reported ADDitIV problems

ADDitIV models

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

• ADDitIV® V1447

  Set, administration, intravascular
  1 recall1 report
• ADDitIV® 352062

  Set, administration, intravascular
  1 recall0 reports
• ADDitIV® 352447

  Set, administration, intravascular
  1 recall0 reports
• ADDitIV® V1443

  Set, administration, intravascular
  1 recall0 reports
• ADDitIV® V1448

  Set, administration, intravascular
  1 recall0 reports
• ADDitIV® V1484

  Set, administration, intravascular
  1 recall0 reports
• ADDitIV® 352079

  Set, administration, intravascular
  1 report

Recent ADDitIV adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): BACKFLOW OF THE PTS BLOOD WAS IN THE IV LINE. UPON OBSERVATION THERE WAS A HOLE IN THE LINE BETWEEN THE PORTS WHICH CAUSED BLOOD TO LEAK ON THE FLOOR AND SPRAY ON OUR TREADMILL CASE SYSTEM. HOW WAS IT DETECTED? A HOLE IN THE IV TUBING CAUSING BLOOD TO LEAK. DESCRIBE REPORTED PROBLEM/EVENT IN DETAIL: (USE ANOTHER SHEET IF NECESSARY) TUBING WAS ATTACHED TO PATIENT AND FLUSHED. HUB WAS CONNECTED FOR PERSANTINE INFUSION. TECH THEN STEPPED AWAY FROM PATIENT TO REVIEW PAPERWORK WITH PHYSICIAN. UPON RETURN TO THE ROOM, THERE WAS SPILL OF BLOOD ALONG THE PROCEDURE ROOM FLOOR AND EQUIPMENT. TEST WAS COMPLETED AND THE PATIENT WAS REMOVED FROM THE AREA AND ROOM WAS WIPED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19212962 ↗
• MalfunctionFeb 3, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE ANESTHESIOLOGIST WAS DRAWING UP FLUID AT LOWER PORT AND PULLED AIR INTO UPPER PORT, THE UPPER PORT WAS NOT LIKELY CAPPED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446199 ↗

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