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Penumbra System 5MAXACE068-BRecalls & reported problems

Penumbra, Inc. · 5MAXACE068-B · 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 00814548017525), received between Jan 17, 2017 and Jan 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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

  • Device Damaged Prior to Use1
  • Kinked1
  • Out-Of-Box Failure1

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.

  • MalfunctionJan 17, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 68 WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

    Patient problems: No Patient Involvement

    MAUDE report 6258505 ↗

Other CATHETER, THROMBUS RETRIEVER devices

All CATHETER, THROMBUS RETRIEVER devices →

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