PINNACLE® 2112341Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04046964200229), received between Aug 25, 2017 and Nov 13, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (17 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: CUSTOMER REPORTS 4 PINNACLE SETS WITH A GREASE LIKE SUBSTANCE ON THE SPIKES. DETAILED INQUIRY DESCRIPTION: I HAVE 4 MORE OF THE PINNACLE SETS THAT HAD THE BLACK "GREASE" ON THEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772424 ↗
• MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: CUSTOMER REPORTS 4 PINNACLE SETS WITH A GREASE LIKE SUBSTANCE ON THE SPIKES. DETAILED INQUIRY DESCRIPTION: I HAVE 4 MORE OF THE PINNACLE SETS THAT HAD THE BLACK "GREASE" ON THEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772423 ↗
• MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: CUSTOMER REPORTS 4 PINNACLE SETS WITH A GREASE LIKE SUBSTANCE ON THE SPIKES. DETAILED INQUIRY DESCRIPTION: I HAVE 4 MORE OF THE PINNACLE SETS THAT HAD THE BLACK "GREASE" ON THEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772422 ↗
• MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: CUSTOMER REPORTS 4 PINNACLE SETS WITH A GREASE LIKE SUBSTANCE ON THE SPIKES. DETAILED INQUIRY DESCRIPTION: I HAVE 4 MORE OF THE PINNACLE SETS THAT HAD THE BLACK "GREASE" ON THEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772421 ↗
• MalfunctionSep 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: 6-LEAD TRANSFER SET FOR USE WITH OUR PINNACLE TPN MANAGEMENT SYSTEM THAT WE OPENED AND HAD BLACK "GREASE" ON LINE 4. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729518 ↗
• MalfunctionApr 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: BLACK INK TYPE SPOT NOTED ON THE SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723095 ↗
• MalfunctionMar 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: PARTICLE FOUND IN TUBING OF TRANSFER SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618019 ↗
• MalfunctionJan 6, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY:. EVENT 2:. INQUIRY DESCRIPTION: FOREIGN RESIDUE FOUND ON THE MANIFOLD SPIKE PORT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16115987 ↗
• MalfunctionJan 6, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: INQUIRY DESCRIPTION: FOREIGN RESIDUE FOUND ON THE MANIFOLD SPIKE PORT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16115972 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: A BROWN SPECK WAS OBSERVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616005 ↗
• MalfunctionJan 6, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  AS REPORTED BY USER FACILITY: CUSTOMER REPORTED THE IDENTIFICATION FLAGS ON LINES 1 AND 2 OF A PINNACLE 6-LEAD TRANSFER SET WERE ON THE WRONG LINES (FLAG 1 ON LINE 2, FLAG 2 ON LINE 1). THE PATIENT ORDER WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175402 ↗
• MalfunctionNov 3, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): BLACK PARTICLES INSIDE NUMBER 6 PUMP SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747280 ↗
• MalfunctionOct 5, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4): PARTICLE SEEN IN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577562 ↗
• MalfunctionMar 3, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  AS REPORTED BY USER FACILITY: WE WENT TO USE ONE OF THE TPN AND IT HAD TWO NUMBER THREE LINES AND NO 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403931 ↗
• MalfunctionJan 15, 2021Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY IN (B)(4): FOREIGN PARTICLE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178766 ↗
• MalfunctionNov 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: WHEN GETTING PREPARED TO SPIKE THE IV BAG, THE CLINICIAN NOTICED A GRAY/BROWN STAIN ON THE SPIKE OF THE TRANSFER SET. SET WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 8045994 ↗
• MalfunctionAug 25, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED: THE BARCODE LABELS FOR TRANSFER LEADS 4, 5, AND 6 WERE MISLABELED. THIS DEFECT WAS FOUND DURING A DEMONSTRATION NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6820072 ↗