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JET 5MAXJETD-ARecalls & reported problems

Penumbra, Inc. · 5MAXJETD-A · 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 00814548019734), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 21, 2019Break; Break

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE A PASS USING THE JETD WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). HOWEVER, WHILE RETRACTING, THE JETD TIP BROKE OFF INSIDE THE DISTAL END OF THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED WITH THE BROKEN TIP INSIDE. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9214128 ↗

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.