SWAN-GANZ CCOMBO V 777F8 (UDI 00885403522348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885403522348), received between Jun 19, 2026 and Jun 19, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

1 other recall cover devices cleared under the same FDA submission (K233824); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Contamination

  AS REPORTED DURING USE THE SWAN GANZ CATHETER WAS MONITORING ERRONEOUS VALUES ON THE CCO. NO ERROR MESSAGE WAS DISPLAYED BUT THE WAVEFORMS WERE ABNORMAL. BLOOD WAS NOTED IN THE BALLOON UPON REMOVAL. THE CATHETER WAS NOT USED TO INFUSE THE DISTAL PORT BUT ONLY TO MONITOR. IT WAS REPLACED ABOUT 12 HOURS AFTER INSERTION. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566610 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233824. One submission often covers many models, so check the product and lot details in each record.

• Z-2202-2026 · Apr 8, 2026 · Open, Classified
  Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;