RED 68 RED68KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948023895), received between Jan 20, 2022 and Jan 20, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K211411); 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.

• MalfunctionJan 20, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN RIGHT MIDDLE CEREBRAL ARTERY (RMCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER DEVICE AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK MAX THEN ADVANCED THE RED68 THROUGH THE BENCHMARK MAX. IT WAS REPORTED THAT THE RED68 WOULD NOT ADVANCE PAST THE OPHTHALMIC ARTERY. THEREFORE, THE PHYSICIAN ADVANCED THE MICROCATHETER AND STENT RETRIEVER DEVICE THROUGH THE RED68 AND SUCCESSFULLY COMPLETED FIVE PASSES. AFTER COMPLETING THE LAST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE RED68. AFTER FEW ATTEMPTS TO RETRACT THE RED68 THE PHYSICIAN PULLED HARDER AND HEARD A NOISE. NEXT, THE PHYSICIAN REMOVED THE STENT RETRIEVER DEVICE AND THE RED68, THEN NOTICED THE RED68 TO BE FRACTURED AND STRETCHED AT APPROXIMATELY 110 CM FROM THE HUB. THE PROCEDURE WAS COMPLETED AT THIS POINT. POST ANGIOGRAPHY SHOWED THAT NO PART OF RED68 WAS LEFT INSIDE THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309042 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211411. One submission often covers many models, so check the product and lot details in each record.

• Z-2770-2026 · Jun 3, 2026 · Open, Classified
  Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT