RED 72 RED72SDKIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00815948029996), received between Jun 17, 2025 and Sep 29, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930803 ↗
• InjuryJul 2, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MCA USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. THE PHYSICIAN PLACED THE BMX96 IN THE COMMON CAROTID ARTERY (CCA) AND PERFORMED A CONTRAST RUN. THE RED72 SILVER AND THE SENDIT WERE ADVANCED TO THE FACE OF THE CLOT. WHILE RETRACTING THE SENDIT FROM THE RED72 SILVER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE SENDIT AND THE RED72 SILVER WERE REMOVED TOGETHER. AFTER REMOVAL, THE PHYSICIAN NOTICED MULTIPLE KINKS ON THE DISTAL END OF THE RED72 SILVER. THE PHYSICIAN ADVANCED A NEW RED72 SILVER AND SENDIT TO THE TARGET LOCATION. THE SENDIT WAS REMOVED TO INITIATE ASPIRATION. AFTER THREE MINUTES OF ASPIRATION NO CLOT WAS ASPIRATED. THE RED72 SILVER WAS REMOVED AND FOUND TO BE FRACTURED AT THE DISTAL END. THE PROXIMAL PORTION WAS REMOVED FROM THE PATIENT. THE REMAINING PORTION EXTENDED FROM THE M1 SEGMENT TO THE EXTERNAL CAROTID ARTERY (ECA). MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE REMAINING PORTION OF THE RED72 SILVER USING A SNARE DEVICE. THE REMAINING PORTION OF THE RED72 SILVER WAS L

  Patient problems: Foreign Body In Patient

  MAUDE report 25700455 ↗
• MalfunctionJul 1, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING THE PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON MAX 6F 088 SHEATH (NEURON MAX), AND A GUIDEWIRE. WHILE REMOVING THE SENDIT FROM THE RED72 SILVER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO RETRACT THE SENDIT AND OBSERVED THAT THE SENDIT WAS FRACTURED UNDER FLUOROSCOPY. THE RED72 SILVER CONTAINING THE SENDIT WAS REMOVED. NO PART OF THE SENDIT WAS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ONE PASS USING ANOTHER RED72 SILVER, ANOTHER SENDIT, THE SAME NEURON MAX, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25684742 ↗
• MalfunctionJun 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. THE PATIENT¿S ANATOMY WAS NOTED TO BE TORTUOUS. THE RED72 SILVER AND SENDIT WERE ADVANCED OVER A GUIDEWIRE AND THROUGH THE NEURON MAX TO THE TARGET LOCATION, AND ASPIRATION WAS PERFORMED. THE PHYSICIAN DECIDED TO RETRACT THE RED72 SILVER. WHILE RETRACTING THE RED72 SILVER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE RHV WAS CHECKED AND CONFIRMED NOT TO BE OVERLY TIGHTENED. THE PHYSICIAN CONTINUED TO RETRACT THE RED72 SILVER, AND NOTICED THAT THE DISTAL TIP WAS NOT MOVING. THE RED72 SILVER AND NEURON MAX WERE SUBSEQUENTLY REMOVED TOGETHER FROM THE PATIENT. ON THE BACK TABLE, THE DISTAL END OF THE RED72 SILVER WAS OBSERVED TO BE UNRAVELING WITHIN THE NEURON MAX. THE RED72 SILVER WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RED72, THE SAME SENDIT, AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609260 ↗
• MalfunctionJun 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A SENDIT DELIVERY DEVICE (SENDIT), A PENUMBRA RED 72 REPERFUSION SILVER CATHETER (RED72 SILVER), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. IT WAS REPORTED THAT A LOOP WAS NOTICED IN THE INTERNAL CAROTID ARTERY (ICA). WHILE ADVANCING THE BMX96 TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT CONTINUED TO USE THE BMX96. THE PHYSICIAN ADVANCED THE RED72 SILVER, SENDIT, AND THE GUIDEWIRE THROUGH THE BMX96 TO THE TARGET LOCATION. THE SENDIT AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT TO INITIATE ASPIRATION. THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS AND NOTICED THAT THE THE DISTAL END OF THE SENDIT AND GUIDEWIRE WERE ASPIRATED ALONG WITH THE CLOT INTO THE PENUMBRA ENGINE CANISTER (CANISTER). ALL PARTS OF THE SENDIT AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608981 ↗
• InjuryApr 24, 2026Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER) AND A PENUMBRA ENGINE (ENGINE). THE PHYSICIAN ADVANCED THE RED72 SILVER TO THE FACE OF THE CLOT AND INITIATED ASPIRATION. DURING THE FIRST PASS, THE PHYSICIAN NOTICED THAT THERE WAS NO FLOW INTO THE CANISTER SO THE RED72 SILVER WAS REMOVED. UPON REMOVAL, THE THE RED72 WAS FOUND TO BE OVALIZED WITH CLOT IN ITS DISTAL TIP AND WAS REMOVED FROM THE PROCEDURE. SUBSEQUENTLY, A SMALL CLOT WAS IDENTIFIED TO HAVE EMBOLIZED IN THE M3 AND WAS TOO DISTAL TO ASPIRATE. A MICROCATHETER WAS THEN USED TO DELIVER A THROMBOLYTIC AGENT (ALTEPLASE) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL ADVERSE EFFECT REPORTED.

  Patient problems: Thromboembolism

  MAUDE report 24987442 ↗
• MalfunctionMar 17, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND AN 8FR SHORT SHEATH. THE PHYSICIAN MADE ONE PASS IN THE TARGET LOCATION USING THE RED72 SILVER TO REMOVE CLOT. AFTER THE PASS, WHILE REMOVING THE RED72 SILVER WITH THE CLOT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PROXIMAL END OF THE RED72 SILVER HAD FRACTURED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617635 ↗
• MalfunctionJan 9, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 SILVER REPERFUSION CATHETER (RED72 SILVER), SENDIT DELIVERY DEVICE (SENDIT), A BALLOON GUIDE CATHETER, A NON-PENUMBRA ASPIRATION CATHETER, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES IN THE RIGHT M1 USING THE THROMBUS RETRIEVAL ASPIRATION PLATFORM (TRAP) TECHNIQUE CONSISTING OF THE BALLOON GUIDE CATHETER, ASPIRATION CATHETER, MICROCATHETER, AND A STENT RETRIEVER RESULTING IN NO REPERFUSION. THE ASPIRATION SYSTEM WAS REMOVED TO BE REPLACED WITH A DIRECT ASPIRATION SYSTEM. A NEW GUIDE CATHETER WAS PLACED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE RED72 SILVER WITH SENDIT WERE ADVANCED OVER A GUIDEWIRE TO THE FACE OF THE CLOT. THE PHYSICIAN REMOVED THE SENDIT DEVICE AND GUIDEWIRE AND INITIATED ASPIRATION FOR APPROXIMATELY 90 SECONDS. UPON RETRACTION UNDER ASPIRATION, THE PHYSICIAN NOTICED THE DISTAL END OF THE RED72 SILVER REMAINED FIXED AT THE FACE OF THE CLOT. THE MICROCATHETER AND GUIDEWIRE WERE ADVANCED THROUGH THE RED72 SILVER TO ASSESS FOR A POTENTIAL KINK AND TO MAINTAIN WIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030912 ↗
• MalfunctionJun 17, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) A SENDIT DELIVERY DEVICE (SENDIT), AND A GUIDE CATHETER. IT WAS REPORTED THAT THE ICA SEGMENT WAS HIGHLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY TRACKING THE SENDIT TO THE TARGET LOCATION BUT WAS ABLE TO DO SO. THE PHYSICIAN COMPLETED SEVERAL PASSES IN THE TARGET LOCATION WITH THE RED72. WHEN REMOVING THE RED72, THE PHYSICIAN ENCOUNTERED RESISTANCE. WHEN THE RED72 WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED IT WAS FRACTURED. THE PHYSICIAN THEN REMOVED THE GUIDE CATHETER AND NOTICED IT WAS KINKED. THE PHYSICIAN BELIEVED THE RED72 DAMAGE WAS DUE TO THE KINK IN THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216891 ↗