Penumbra System 3MAXCKIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548019963), received between Aug 26, 2022 and Aug 26, 2022 — 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

Recent adverse event reports

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

• MalfunctionAug 26, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN BROKE A 3MAXC AT THE PROXIMAL END NEAR THE HUB UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE 3MAXC OCCURRED PRIOR TO USE; THEREFORE, THE 3MAXC WAS NOT USED IN THE PROCEDURE. THEN, THE PHYSICIAN BROKE A 3MAXC AT THE DISTAL END IN THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN ASPIRATED THE BROKEN DISTAL PIECE OF THE 3MAXC OUT OF THE PATIENT AND INTO THE CANISTER. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302721 ↗