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FlowPort CAT00778Recalls & reported problems

Stryker Corporation · Class 1

All models of FlowPort (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252632917), received between Jul 15, 2020 and Jul 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Fluid/Blood Leak1
  • Leak/Splash1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 15, 2020Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak

    IT WAS REPORTED THERE WAS INCREASED TRACTION TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10276362 ↗
  • MalfunctionJul 15, 2020Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash

    IT WAS REPORTED THERE WAS INCREASED TRACTION TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10276357 ↗

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Sources and updates

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