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NA APU452Recalls & reported problems

Medtronic, Inc. · AORTIC PUNCH SH 452 SUA · Class 1

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 20763000122175), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionAug 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF THIS AORTIC PUNCH, THE DEVICE MISFIRED AND TISSUE BECAME STUCK INSIDE THE DEVICE. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 17459774 ↗

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