RED 72 RED72KIT-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948029989), received between May 9, 2025 and Jul 1, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A NON-PENUMBRA SHEATH (7F), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. THE RED72 SILVER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. WHILE REMOVING THE RED72 SILVER FROM THE PATIENT IT WAS NOTICED UNDER FLUOROSCOPY THAT THE CATHETER FRACTURED. A SNARE DEVICE WAS USED TO REMOVE THE RED72 SILVER FROM THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25685207 ↗
• MalfunctionSep 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A SHEATH, A NON-PENUMBRA STENT RETRIEVER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE RED72 SILVER AND THE STENT RETRIEVER. AFTER COMPLETING A PASS USING THE RED72 SILVER AND STENT RETRIEVER, BOTH DEVICES WERE REMOVED. WHILE REMOVING, THE DISTAL END OF THE RED72 SILVER FRACTURED IN THE TARGET VESSEL. THE FRACTURE WAS VISUALIZED UNDER FLUOROSCOPY. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED SEGMENT OF THE RED72 SILVER IN THE ECA. THE PROCEDURE WAS COMPLETED USING A NEW RED72 SILVER AND THE SAME SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 23100296 ↗
• InjuryMay 9, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS BUT NOT OVERLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 OVER THE RED72 SILVER. NEXT, THE PHYSICIAN TURNED ON ASPIRATION AND RETRACTED THE RED72 SILVER AND NOTICED THAT THE DISTAL END OF THE RED72 SILVER WAS NOT MOVING. SUBSEQUENTLY, THE PHYSICIAN FELT RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE RED72 SILVER WAS FRACTURED. THE PHYSICIAN MADE THE DECISION TO LEAVE THE FRACTURED CATHETER IN THE LEFT TERMINUS SECTION OF THE INTERNAL CAROTID ARTERY (ICA). IT WAS REPORTED THAT THE CATHETER THAT WAS LEFT IN PLACE DID NOT WORSEN THE PATIENT'S INITIAL SYMPTOMS. THE PATIENT WAS INTUBATED AND KEPT IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT HAD A SUBSEQUENT HEMICRANIECTOMY DUE TO THE INITIAL LARGE INFARCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21993163 ↗