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Park G03432Recalls & reported problems

Cook Incorporated · Park Blade Septostomy Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002034327), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Open or Close1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 18, 2018Difficult to Open or Close

    IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE BLADE OF THE PARK BLADE SEPTOSTOMY CATHETER WOULD NOT OPEN. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8173916 ↗

Other CATHETER, SEPTOSTOMY devices

All CATHETER, SEPTOSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.