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Cook G26655Recalls & reported problems

Cook Incorporated · One-Step Suprapubic Introducer · Class 2

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

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 00827002266551), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionApr 23, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT THE ONE-STEP SUPRAPUBIC INTRODUCER WAS RECEIVED WITH A HOLE THROUGH THE PACKAGING. THE USER STATED THAT ONLY THIS DEVICE IN THE BOX WAS DAMAGED, LOOKED LIKE IT HAD LITTLE PINHOLES IN THE PACKAGING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Patient problems: No Patient Involvement

    MAUDE report 7451882 ↗

Other CATHETER, SUPRAPUBIC (AND ACCESSORIES) devices

All CATHETER, SUPRAPUBIC (AND ACCESSORIES) devices →

Sources and updates

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