RED 72 RED72SDKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00815948025943), received between Jul 18, 2023 and Dec 18, 2025 — classified as 3 deaths, 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 reports).

4 other recalls cover devices cleared under the same FDA submission (K191946, K211654); 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Stretched; Fracture; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, AFTER PERFORMING ONE PASS IN THE TARGET VESSEL USING THE RED72, THE PHYSICIAN DECIDED TO REMOVE THE RED72. WHILE RETRACTING THE RED72, THE PHYSICIAN NOTICED THAT THE DISTAL LENGTH OF THE CATHETER WAS NOT RETRACTING AND OBSERVED UNDER FLUOROSCOPY THAT THE RED72 WAS BECOMING STRETCHED AND DAMAGED. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE ENTIRE RED72 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED72 AND THE SAME BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843594 ↗
• MalfunctionMar 10, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND THE RIGHT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING A SENDIT DELIVERY DEVICE (SENDIT) AND A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72). IT SHOULD BE NOTED THAT THE PATIENT'S CAROTID SIPHON WAS TORTUOUS AND THE A1 HAD A SHARP CURVE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS IN THE M1 USING THE RED72 AND THE SENDIT. THE SENDIT AND RED72 WERE THEN ADVANCED TO THE A2 WITHOUT DIFFICULTY. WHILE REMOVING THE SENDIT FROM THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE SENDIT INSIDE THE RED72. THE FRACTURED SENDIT SEGMENT AND THE THROMBUS WERE THEN ASPIRATED INTO THE PENUMBRA ENGINE CANISTER (CANISTER) THROUGH THE RED72. AT THIS POINT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561054 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED NINE PASSES USING THE RED72. WHILE RETRACTING THE RED72, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RED72 FRACTURED AT THE DISTAL LENGTH AND REMAINED IN THE VESSEL. THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER TO REMOVE THE FRACTURED SEGMENT OF THE RED72. THE PROCEDURE WAS COMPLETED USING A NEW RED72, THE SAME STENT RETRIEVER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439558 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), AND A NON-PENUMBRA ASPIRATION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 AND SENDIT TO THE TARGET VESSEL. WHILE RETRACTING THE SENDIT, THE PHYSICIAN FRACTURED THE RED72. AFTER REMOVING THE SENDIT, THE PHYSICIAN ADVANCED AN ASPIRATION CATHETER PAST THE FRACTURED SEGMENT OF THE RED72 AND REMOVED THE THROMBUS. THE PHYSICIAN THEN USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE RED72. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439041 ↗
• MalfunctionDec 27, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE GUIDE CATHETER WITH THE RED72 AND SENDIT. THE PHYSICIAN THEN REMOVED THE SENDIT AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL PORTION OF THE SENDIT FROM THE MID-SHAFT WAS FRACTURED INSIDE THE RED72. THEREFORE, THE RED72 CONTAINING THE FRACTURED SENDIT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028497 ↗
• MalfunctionNov 1, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS IN THE TARGET LOCATION USING THE RED72. AFTER THE PASS, THE PHYSICIAN NOTICED THERE WAS NO SIGNIFICANT FLOW UNDER ASPIRATION WITH THE RED72 AND THE RED72 BECAME CLOGGED WITH CLOT. THE PHYSICIAN DECIDED TO REMOVE THE RED72; HOWEVER, WHILE REMOVING THE RED72 OUT FROM THE TARGET LOCATION, THE DISTAL END OF THE RED72 HAD FRACTURED OUTSIDE THE TIP OF THE GUIDE CATHETER IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THEREFORE, THE PHYSICIAN MADE SEVERAL ATTEMPTS USING THE GUIDE CATHETER UNDER ASPIRATION TO SUCCESSFULLY REMOVE THE FRACTURED DISTAL END OF THE RED72 TOGETHER WITH THE GUIDE CATHETER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE CATHETER, NON-PENUMBRA ASPIRATION CATHETER, NON-PENUMBRA MICROCATHETER, AND GUIDEWIRE TO ACHIEVE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588655 ↗
• MalfunctionOct 31, 2024Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA SHEATH (8F). DURING THE PROCEDURE, THE RIGHT FEMORAL ARTERY WAS ACCESSED WITH THE SHEATH. THE PHYSICIAN ADVANCED A BMX96 AND RED72 TO THE TARGET LOCATION. IT WAS REPORTED THAT THE RED72 WAS UNABLE TO BE ADVANCED PAST THE CAVERNOUS SEGMENT OF THE ICA. THE PHYSICIAN THEN ADVANCED A RED43 THROUGH THE RED72 TO THE TARGET LOCATION. AFTER INITIATING ASPIRATION, THE DISTAL PORTION OF THE RED43 WAS NOTICED TO BE FRACTURED UNDER FLUOROSCOPY. THE FRACTURED SEGMENT OF THE RED43 WAS NOTICED TO BE AGAINST THE THROMBUS IN THE M1. THE PHYSICIAN REMOVED THE PROXIMAL SEGMENT OF THE RED43. NEXT, WHILE REMOVING THE RED72 FROM THE BMX96, THE PHYSICIAN NOTED RESISTANCE. THE PHYSICIAN THEN DECIDED TO REMOVE THE RED72 AND BMX96 TOGETHER FROM THE PATIENT, HOWEVER, RESISTANCE WAS ENCOUNTERED AND, SUBSEQUENTLY, THE RED72 AND BMX96 STRETCHED AND FRACTURED AT THE DISTAL LOCATION WITHIN THE SHEAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582885 ↗
• DeathOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE L M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A DIAGNOSTIC CATHETER (5F), GUIDEWIRES, A CLOSURE DEVICE, AND A SHEATH (8FR) VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE RED72 WAS POSITIONED IN THE PROXIMAL L M1 SEGMENT (PROXIMAL TO THE CLOT) OVER THE SENDIT AND GUIDEWIRE. THE SENDIT AND GUIDEWIRE WERE THEN WITHDRAWN. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 INTO THE CLOT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE CLOT COULD NOT BE REACHED. NEXT, THE RED72 WAS WITHDRAWN INTO THE DISTAL L SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). A ROADMAP ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED NEW OCCLUSION OF THE DISTAL L POSTERIOR COMMUNICATING ARTERY (PCA). THE RED72 WAS ADVANCED TO THE CLOT OVER A GUIDEWIRE INTO THE DISTAL L MCA. TWO PASSES WERE COMPLETED. A CONTROL RUN DEMONSTRATED NEAR-COMPLETE REVASCULARIZATION OF THE L M2 INFERIOR DIVISION WITH PERSISTENT OCCLU

  Patient problems: Stroke/CVA; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 20434090 ↗
• DeathOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE L M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A DIAGNOSTIC CATHETER (5F), GUIDEWIRES, A CLOSURE DEVICE, AND A SHEATH (8FR) VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE RED72 WAS POSITIONED IN THE PROXIMAL L M1 SEGMENT (PROXIMAL TO THE CLOT) OVER THE SENDIT AND GUIDEWIRE. THE SENDIT AND GUIDEWIRE WERE THEN WITHDRAWN. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 INTO THE CLOT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE CLOT COULD NOT BE REACHED. NEXT, THE RED72 WAS WITHDRAWN INTO THE DISTAL L SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). A ROADMAP ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED NEW OCCLUSION OF THE DISTAL L POSTERIOR COMMUNICATING ARTERY (PCA). THE RED72 WAS ADVANCED TO THE CLOT OVER A GUIDEWIRE INTO THE DISTAL L MCA. TWO PASSES WERE COMPLETED. A CONTROL RUN DEMONSTRATED NEAR-COMPLETE REVASCULARIZATION OF THE L M2 INFERIOR DIVISION WITH PERSISTENT OCCLU

  Patient problems: Vascular Dissection

  MAUDE report 20433837 ↗
• InjuryOct 11, 2024Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS WITH ACUTE TURNS. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE RED72 WAS DIFFICULT TO ADVANCE AND IT REQUIRED SEVERAL ATTEMPTS TO TRACK THE RED72 TO THE TARGET LOCATION. AFTER COMPLETING ONE PASS, THE PHYSICIAN DECIDED TO REMOVE THE RED72. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE WHILE REMOVING THE RED72. AFTER REMOVAL, THE RED72 APPEARED TO BE KINKED AND STRETCHED AT THE DISTAL LOCATION. THE PROCEDURE WAS COMPLETED WITH A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43). ON (B)(6) 2024, THE PATIENT EXPERIENCED A GENERALIZED TONIC-CLONIC SEIZURE EVENT LASTING ONE MINUTE. THE SEIZURE WAS TREATED WITH MEDICATION (ATIVAN). IT WAS REPORTED THAT THE SEIZURE OCCURRED DUE TO RE-OCCLUSION. A CT SCAN FOUND RE-OCCLUSION IN THE MCA/M2 ARTERIES. THE PATIENT WAS PUT ON SINGLE ANTIPLATELET MEDICATION AND DISCHARGED ON (B)(6) 2024. THE PATIENT EXITED THE STUDY ON (B)(6) 2024 AND THE EVENT WAS CONSIDERED UNRESOLVED AT THE TIME OF STUDY EXIT. ON (B

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20433706 ↗
• MalfunctionSep 9, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE (0.014). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS WITH A SIGNIFICANT TURN AT THE INTERNAL CAROTID ARTERY (ICA) TERMINUS AND MCA. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RED72 AND SENDIT PAST THE ICA TERMINUS. THE RED72 AND THE SENDIT WHERE ADVANCED TO THE TARGET LOCATION, THE PHYSICIAN THEN EXPERIENCED RESISTANCE AGAIN WHILE REMOVING THE GUIDEWIRE AND THE SENDIT. THE PHYSICIAN CONTINUED TO PULL THE SENDIT FROM THE RED72 AND IT WAS REPORTED THERE WAS A RELEASE OF PRESSURE. UPON REMOVAL OF THE SENDIT, THE PHYSICIAN NOTICED THAT TEN CENTIMETERS OF THE SENDIT DISTAL LENGTH WAS MISSING. ASPIRATION WAS INITIATED ON THE RED72 TO SECURE THE FRACTURED SEGMENT OF THE SENDIT UNDER FLUOROSCOPY. THE RED72 CONTAINING THE FRACTURED SEGMENT OF THE SENDIT WAS REMOVED FROM THE PATIENT. THE FRACTURED SEGMENT OF THE SENDIT WAS THEN FLUSHED OUT OF THE RED72 ON THE BACK TABLE. IT WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177177 ↗
• InjurySep 6, 2024Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A NON-PENUMBRA SHEATH, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RED72. WHILE RETRACTING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND STRETCHED AND FRACTURED THE RED72 AT THE DISTAL END. IT WAS REPORTED THAT THE SHEATH BECAME KINKED AND PINCHED THE RED72 DUE TO THE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND THE BENCHMARK BMX96 ACCESS SYSTEM (BMX96). IT WAS REPORTED THAT THE FRACTURED DISTAL END OF THE RED72 WAS REMOVED USING A SNARE DEVICE AT A LATER DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20162168 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND A GUIDEWIRE. DURING THE PROCEDURE, THE RED72 WAS ADVANCED WITH THE SENDIT TO THE TARGET LOCATION. THE SENDIT WAS REMOVED, AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 TO THE CLOT INTERFACE; HOWEVER, THE RED72 WOULD NOT ADVANCE. THE PHYSICIAN DECIDED TO REMOVE THE RED72. WHILE THE RED72 WAS BEING REMOVED FROM THE SHEATH, THE RED72 UNRAVELED. IT WAS REPORTED THAT THE RED72 AND THE BMX96 WERE REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED USING A NEW RED72, A NEW SENDIT, AND THE SAME BMX96. ON 5-JUNE-2024, A CLINICAL NOTIFICATION WAS RECEIVED INDICATING EMBOLI INFARCT IN A NEW TERRITORY ANTERIOR CEREBRAL ARTERY (ACA) WAS NOTICED DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A FETAL TYPE OF VARIANT POSTERIOR COMMUNICATING ARTERY (PCA). EMBOLI INFARCT WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE. THE PATIENT WAS ADMINISTERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581976 ↗
• InjuryMar 12, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA STENT RETRIEVER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT RETRIEVER ALONG WITH THE RED72 WAS ADVANCED TO THE TARGET LOCATION AND REMOVED UNDER ASPIRATION THREE TIMES WITHOUT SUCCESSFUL RECANALIZATION OF THE VESSEL. WHILE ATTEMPTING TO REMOVE THE STENT RETRIEVER AND THE RED72 ON THE FINAL ATTEMPT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE STENT RETRIEVER AND THE RED72 WERE FRACTURED. IT WAS REPORTED THAT THE RED72 FRACTURED AT THE DISTAL END. THE PHYSICIAN THEN SNARED THE RED72. THE FRACTURED STENT RETRIEVER WAS LEFT IN THE BODY AFTER MULTIPLE ATTEMPTS TO REMOVE. THE PROCEDURE ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18890756 ↗
• MalfunctionMar 8, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA SHEATH, A NON-PENUMBRA STENT RETRIEVER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 WITH SENDIT INTO THE TARGET LOCATION OVER A GUIDEWIRE. THE SENDIT WAS THEN REMOVED, AND THE PHYSICIAN INITIATED ASPIRATION USING THE RED72. AFTER A COUPLE OF MINUTES OF ASPIRATING, THE PHYSICIAN PULLED ON THE RED72 AND FELT A TUG. IT WAS REPORTED THAT THE DISTAL THIRD OF THE RED72 WAS FRACTURED. THEREFORE, THE SHEATH AND RED72 WAS REMOVED TOGETHER AS A UNIT. THE PHYSICIAN PLACED A NEW SHEATH AND ADVANCED A NEW RED72 INTO THE VESSEL. AFTER MAKING THREE MORE PASSES USING THE RED72, THE CLOT COULD NOT BE REMOVED. THE PHYSICIAN THEN REMOVED THE RED72 AND SWITCHED TO A RED62 WITH A STENT RETRIEVER; HOWEVER, THE PHYSICIAN WAS ONLY ABLE TO REMOVE A SMALL AMOUNT OF CLOT USING THE STENT RETRIEVER. THE RED62 AND STENT RETRIEVER WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871238 ↗
• MalfunctionFeb 23, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. UPON REMOVAL, THE RED72 WAS NOTICED TO BE FRACTURED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH A NEW RED72, THE SAME BMX96, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773795 ↗
• DeathJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE ANTERIOR CIRCULATION OF THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 5F (5F SELECT), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT RECEIVED 18 MG OF THROMBOLYTIC THERAPY AND SINGLE ANTIPLATELET MEDICATION PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE LEFT M2 SEGMENT USING THE RED62. THE RED62 WAS RETRACTED TO PERFORM AN ANGIOGRAM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). ADDITIONAL CLOT WAS NOTICED IN THE RIGHT PERICALLOSAL ARTERY. THE PHYSICIAN THEN ADVANCED A RED43 INTO THE DISTAL RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND INTO THE RIGHT PERICALLOSAL ARTERY AND COMPLETED ONE PASS USING THE RED43. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 WAS ACHIEVED. POST-THROMBECTOMY, IT WAS REPORTED THE PATIENT CONTINUED TO HAVE PE

  Patient problems: Cerebral Edema; Ischemia Stroke

  MAUDE report 18481439 ↗
• MalfunctionDec 15, 2023Fracture; Stretched; Fracture; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, IT WAS REPORTED THAT THE DISTAL END OF THE RED72 WAS STRETCHED AND THEN FRACTURED WHILE INSIDE THE PATIENT. THEREFORE, THE RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18339527 ↗
• MalfunctionNov 10, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 AND SENDIT TO THE FACE OF THE CLOT IN THE TARGET VESSEL; HOWEVER, WHILE ATTEMPTING TO REMOVE THE SENDIT FROM THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN WAS ABLE TO REMOVE THE SENDIT WITH SOME FORCE. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE SENDIT WAS NOT CONNECTED. THEREFORE, THE RED72 WAS REMOVED AND THE DISTAL END OF THE SENDIT WAS FOUND INSIDE THE RED72. THE PROCEDURE WAS COMPLETED USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NEW RED72 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 18114453 ↗
• MalfunctionNov 3, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON 6F 088 LONG SHEATH, AND A MICROWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 WITH THE SENDIT OVER THE GUIDEWIRE UP TO THE ICA AND INTO THE MCA. THE PHYSICIAN REMOVED THE SENDIT AND PERFORMED ONE PASS USING THE RED72. AFTER COMPLETION OF THE PASS, A CONTRAST RUN REVEALED SMALL RESIDUAL FLOW WITH NARROWING IN THE MCA. THE PHYSICIAN THEN ADVANCED THE RED72 AND NOTICED THAT THE RED72 WOULD NOT ADVANCE FORWARD. WHILE REMOVING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE RED72 FRACTURED AT TWO LOCATIONS NEAR THE DISTAL PART WITHIN THE NEURON MAX. THE FRACTURED PIECES OF THE RED72 WERE CONTAINED WITHIN THE NEURON MAX. A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED PIECES OF THE RED72 WITHIN THE NEURON MAX. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), THE SAME NEURON MAX, AND THE SAME MICROWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070086 ↗
• MalfunctionOct 23, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA GUIDE CATHETER. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 AND SENDIT TO THE TARGET LOCATION AND COMPLETED ONE PASS. IT WAS REPORTED THAT THE PASS RESULTED IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B. DURING THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RED72 FRACTURED. THE PHYSICIAN THEN REMOVED THE RED72 AGAINST RESISTANCE. UPON REMOVAL, APPROXIMATELY TWENTY CENTIMETERS OF THE DISTAL PORTION OF THE RED72 WAS MISSING AND REMAINED IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN THEN USED A SNARE DEVICE AND REMOVED THE REMAINING PORTION OF THE RED72 FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A NEW RED72, A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), THE SAME SHEATH, AND A NON-PENUMBRA MICROWIRE RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989117 ↗
• MalfunctionOct 20, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), AND A GUIDEWIRE (0.014). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS INITIALLY ADVANCING THE RED72 WITH SENDIT TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE SENDIT MID-SHAFT. THEREFORE THE RED72 CONTAINING THE FRACTURED SENDIT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A PENUMBRA SYSTEM MAX 3 REPERFUSION CATHETER (3MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978066 ↗
• MalfunctionOct 2, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY (BA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, A GLIDEWIRE, AND A GUIDEWIRE. IT WAS NOTED THAT STENOSIS WAS AT THE VERTEBRAL ARTERY ORIGIN. DURING THE PROCEDURE, A NEURON MAX WAS ADVANCED INTO THE RIGHT VERTEBRAL ARTERY OVER THE GUIDEWIRE AND 5F SELECT TO THE TARGET LOCATION. THE GUIDEWIRE AND 5F SELECT WERE THEN REMOVED AND AN ANGIOGRAPHY WAS PERFORMED THAT REVEALED BOTH PROXIMAL AND DISTAL BASILAR OCCLUSIONS. THE RED72 AND SENDIT WERE ADVANCED THROUGH THE NEURON MAX TO THE FACE OF THE PROXIMAL CLOT. WHILE REMOVING THE SENDIT, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN GENTLY SHOOK THE SENDIT AND RETRACTED THE SENDIT SIMULTANEOUSLY OUT OF THE PATIENT. THE RED72 WAS REMOVED FROM THE PATIENT AND WAS FLUSHED. IT WAS REPORTED A FOCAL STREAM WAS NOTICED WHEN FLUSHING THE RED72 AND THE PHYSICIAN INDICATED THAT THE DISTAL PORTION OF THE SENDIT WAS MISSING. ANOTHER ANGIOGRAM WAS PERFORMED TO ENSURE THERE WAS NOTHING REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852752 ↗
• MalfunctionSep 29, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE RED72 WAS FRACTURED AT THE MID-SHAFT. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE FRACTURED SEGMENT OF THE RED72 AND THE GUIDE SHEATH TOGETHER; HOWEVER, THE REMAINING PORTION OF THE RED72 COULD NOT BE PULLED OUT. NEXT, THE PHYSICIAN USED A NON-PENUMBRA STENT RETRIEVER THROUGH A NON-PENUMBRA MICROCATHETER TO REMOVE THE FRACTURED SEGMENT BUT WAS UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848840 ↗
• MalfunctionSep 22, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), SENDIT DELIVERY DEVICE (SENDIT), NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 WITH THE SENDIT TO TARGET LOCATION. WHEN THE PHYSICIAN UNSCREWED THE SENDIT FROM THE HUB AND BEGAN RETRACTING IT FROM THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE SENDIT AT THE DISTAL LOCATION. THEREFORE, THE RED72 CONTAINING THE FRACTURED SENDIT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804797 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191946, K211654. One submission often covers many models, so check the product and lot details in each record.

• Z-0850-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Fle
• Z-0851-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex
• Z-0848-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7
• Z-0849-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) i