Penumbra System ACE683DVELSYS-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948020085), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113163, K152840, K160449, K162901); they may or may not involve this specific model.

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 22, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, WHILE ADVANCING THE PSR3D THROUGH A VELOCITY DELIVERY MICROCATHETER (VELOCITY), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PSR3D BECAME KINKED; THEREFORE, THE PRS3D AND THE VELOCITY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PRS3D AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113163, K152840, K160449, K162901. One submission often covers many models, so check the product and lot details in each record.

• Z-2702-2017 · Jun 9, 2017 · Terminated
  Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disea