PINNACLERecalls & reported problems across all models

We found 13 models of PINNACLE by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2016 and Sep 25, 2026 — classified as 1 injury, 114 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (63 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

Most reported PINNACLE problems

PINNACLE models

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

• PINNACLE® 601184

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  25 reports
• PINNACLE® 2112341

  Set, i.V. Fluid transfer
  20 reports
• PINNACLE® 2112349

  CONTAINER, I.V.
  13 reports
• PINNACLE® 2112348

  CONTAINER, I.V.
  11 reports
• PINNACLE® PC1000

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  11 reports
• PINNACLE® 2112350

  CONTAINER, I.V.
  10 reports
• PINNACLE® 2112342

  Set, i.V. Fluid transfer
  8 reports
• PINNACLE® 2112431

  CONTAINER, I.V.
  6 reports
• PINNACLE® 2112351

  CONTAINER, I.V.
  4 reports
• PINNACLE® 2112346

  CONTAINER, I.V.
  2 reports
• PINNACLE® 2112347

  CONTAINER, I.V.
  2 reports
• PINNACLE® 2112407

  CONTAINER, I.V.
  2 reports
• PINNACLE® 601192

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  1 report

Recent PINNACLE adverse event reports

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

• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898565 ↗
• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  As reported by the user facility:I am just reaching out to let you guys know that we have stumbled upon our 3L TPN B-Braun bags having blue fibers in them!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898562 ↗
• MalfunctionSep 23, 2026Contamination /Decontamination Problem

  According to the complainant, prior to use, a hair was observed inside a Pinnacle Single Chamber Mixing Container. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871150 ↗
• MalfunctionApr 24, 2026Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINANT, DURING INCOMING RAW MATERIAL INSPECTION, ONE (1) PARTICULATE MATTER WAS OBSERVED IN A PINNACLE 4000 MILLILITER (ML) EVA MIXING CONTAINER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987160 ↗
• MalfunctionMar 24, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: FOREIGN MATTER WAS FOUND IN THE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675106 ↗
• MalfunctionMar 6, 2026Application Program Problem: Dose Calculation Error

  THE COMPLAINANT REPORTED OPERATIONAL MALFUNCTIONS INVOLVING A PINNACLE TPN MANAGEMENT SYSTEM. ACCORDING TO THE REPORT, THE UNIT DELIVERED INACCURATE VOLUMES DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING. IN ONE EXAMPLE, THE SYSTEM WAS PROGRAMMED AND CALCULATED FOR EIGHT (8) TPN BAGS; HOWEVER, THE DEVICE DISPENSED QUANTITIES SUFFICIENT FOR ONLY SEVEN (7) BAGS. THE DISCREPANCY WAS IDENTIFIED DURING THE FACILITY'S DOUBLE-CHECK VERIFICATION PROCESS PRIOR TO PATIENT ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531058 ↗
• MalfunctionMar 6, 2026Application Program Problem: Dose Calculation Error

  THE COMPLAINANT REPORTED OPERATIONAL MALFUNCTIONS INVOLVING A PINNACLE TPN MANAGEMENT SYSTEM. ACCORDING TO THE REPORT, THE UNIT DELIVERED INACCURATE VOLUMES DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING. IN ONE EXAMPLE, THE SYSTEM WAS PROGRAMMED AND CALCULATED FOR EIGHT (8) TPN BAGS; HOWEVER, THE DEVICE DISPENSED QUANTITIES SUFFICIENT FOR ONLY SEVEN (7) BAGS. THE DISCREPANCY WAS IDENTIFIED DURING THE FACILITY'S DOUBLE-CHECK VERIFICATION PROCESS PRIOR TO PATIENT ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531057 ↗
• MalfunctionMar 2, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: A SMALL PARTICULATE WAS IDENTIFIED IN A CERTAIN LOT OF PINNACLE 1L BAGS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482225 ↗
• MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  FOREIGN MATTER FLUID PATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853341 ↗
• MalfunctionDec 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: HI GOOD MORNING, ATTACHING THE PHOTOS OF OUR TPN WITH THE PLENAMINE ADDED. THEY ARE SLIGHTLY MORE YELLOW IN PERSON BUT NOT COMING THROUGH IN THE PHOTOS. THE BAG ON THE LEFT WAS THE BAG WE COMPOUNDED ON (B)(6) AND THE BAG ON THE RIGHT IS THE BAG WE COMPOUNDED YESTERDAY (B)(6). AS MORE TIME PASSES, THE BAGS SEEM TO BE GETTING SLIGHTLY MORE YELLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756754 ↗
• MalfunctionDec 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, TWO PARTICULATE MATTER EMBEDDED DEFECTS WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703850 ↗
• MalfunctionNov 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINANT, FIBERS WERE FOUND INSIDE BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547255 ↗
• MalfunctionNov 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINANT, FIBERS WERE FOUND INSIDE BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544827 ↗
• MalfunctionOct 20, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  EVENT 2 ACCORDING TO THE COMPLAINANT, BLACK SPECKS WERE FOUND IN THE TRANSFER SET TUBING AND INSIDE THE PLASTIC BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335664 ↗
• MalfunctionOct 20, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  EVENT 1: ACCORDING TO THE COMPLAINANT, BLACK SPECKS WERE FOUND IN THE TRANSFER SET TUBING AND INSIDE THE PLASTIC BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335661 ↗

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