RED 68 RED68-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948024090), received between Nov 21, 2022 and Jul 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA SHEATH, A STENT RETRIEVER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED PASSES IN THE TARGET LOCATION USING THE RED68 AND 3MAXC. THE PHYSICIAN THEN RE-ADVANCED THE RED68 AND 3MAXC TO THE CLOT AND ATTEMPTED TO ADVANCE THE STENT RETRIEVER THROUGH THE RED68. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN PLACING THE RED68 AND STENT RETRIEVER DUE TO THE PATIENT¿S ANATOMY, CAUSING THE PHYSICIAN TO USE ADDITIONAL FORCE. AFTER SEVERAL ATTEMPTS TO ADVANCE THE STENT RETRIEVER, THE PHYSICIAN DECIDED TO REMOVE IT WITH THE RED68 AND 3MAXC AND AGAIN EXPERIENCED RESISTANCE. UPON REMOVAL, IT WAS NOTED THAT BOTH THE RED68 AND THE 3MAXC FRACTURED INTO TWO PIECES APPROXIMATELY FIVE CENTIMETERS FROM THE PROXIMAL END. THEREFORE, THE RED68 AND THE 3MAXC WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION CATHETER AND THE SAME SHEATH. THERE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696754 ↗
• MalfunctionNov 21, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH IN THE PATIENT USING RIGHT RADIAL ACCESS. WHILE ADVANCING THE RED68 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, BROKE THE RED68 INTO TWO PIECES AT THE MID-SHAFT AREA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN RED68. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH, ANOTHER CATHETER, AND A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840083 ↗

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