ICU Medical CH-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619025779), received between Oct 29, 2023 and Feb 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Particulates” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K080989); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Particulates

  OPERATORS OBSERVED A PARTICULATE IN VIAL 1 OF 7 OF VIRAL VECTOR FIN V20006 V1.3 SYMB (GLOBAL) PRIOR TO WITHDRAWING THE REQUIRED VOLUME FOR MVP 1 WHEN USING THE UNIVERSAL VENTED VIAL SPIKE, CLAVE®. THIS OCCURRED DURING THE MEDIA VIRUS PROTAMINE SULFATE (MVP) PACK ALIQUOT GLB4 200 FORMULATION. THE VIAL HAD BEEN INSPECTED BY THE OPERATOR PER (B)(4), CTO NETWORK VISUAL INTEGRITY CHECK BEFORE SPIKING. IT WAS THEREFORE SURMISED THAT A PORTION OF THE VIAL SEPTUM SHEARED OFF AFTER BEING SPIKED WITH THE VENTED VIAL SPIKE. IN ADDITION, THE CUSTOMER STATED THAT PER (B)(4), CHARACTERIZATION OF PARTICULATE IN VIRAL VECTOR VIAL FROM BOTHELL, PARTICLE ANALYSIS CONFIRMED THE PARTICLE WAS MORPHOLOGICALLY AND CHEMICALLY CONSISTENT WITH THE SEPTUM OF THE VIRAL VECTOR VIAL. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283930 ↗
• MalfunctionNov 4, 2023Particulates; Device Contamination with Chemical or Other Material; Particulates; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A UNIVERSAL VENTED VIAL SPIKE, CLAVE®. THE CUSTOMER REPORTED, PARTICULATE (CHARACTERIZED AS POLYETHYLENE TEREPHTHALATE (PET)) HAS BEEN OBSERVED IN CLINIMACS PBS/EDTA BUFFER ASSOCIATED WITH VIAL SPIKE W/ CLAVE DUAL VENTED IV ACCESS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070360 ↗
• MalfunctionNov 3, 2023Contamination; Particulates; Contamination; Particulates

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A UNIVERSAL VENTED VIAL SPIKE, CLAVE®. IT WAS REPORTED PARTICULATE (CHARACTERIZED AS ACRYLONITRILE BUTADIENE STYRENE (ABS) COPOLYMER) WAS OBSERVED IN IN THE CELL CULTURE IN THE AMAT BAG DURING THE ACTIVATION ASSOCIATED WITH VIAL SPIKE W/ CLAVE DUAL VENTED IV ACCESS. THERE WAS NO HUMAN HARM REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068826 ↗
• MalfunctionOct 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A UNIVERSAL VENTED VIAL SPIKE, CLAVE® WHERE IT WAS REPORTED, THE BLUE FOREIGN PIECE YOU SEE ON THE TAMPON WAS IN THE SIDE HOLE OF THE SPIKE AND YOU ALSO SEE SOME STILL IN THE HOLE. THIS OCCURRED WHEN THE 'UNIVERSAL VENTED VIAL SPIKE, CLAVE' WAS UNPACKED. THIS IS A PRODUCT THAT THEY USE TO PUT ON THEIR ONCOLOGY VIALS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080989. One submission often covers many models, so check the product and lot details in each record.

• Z-0710-2021 · Aug 31, 2020 · Open, Classified
  Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260