RED 43 RED43160-ARecalls & reported problems
Penumbra, Inc. · Reperfusion Catheter RED 43, 160cm, no CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00815948025745), received between Aug 14, 2023 and May 6, 2026 — classified as 1 death, 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture12
- Physical Resistance/Sticking6
- Adverse Event Without Identified Device or Use Problem2
- Material Deformation1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Foreign Body In Patient2
- Cerebral Edema1
- Ischemia Stroke1
- Vascular Dissection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). THE PHYSICIAN ADVANCED THE RED62 TO THE TARGET LOCATION OVER THE RED43. WHILE RETRACTING THE RED43, THE PHYSICIAN EXPERIENCED RESISTANCE. WHEN THE RED43 WAS COMPLETELY RETRACTED INTO THE RED62, THE PHYSICIAN FOUND THAT THE RED43 HAD FRACTURED. THEREFORE, THE RED62 AND THE RED43 WERE REMOVED TOGETHER FROM THE PATIENT UNDER ASPIRATION. NO PART OF THE RED43 REMAINED IN THE PATIENT. THE RED62 WAS NO LONGER USED IN THE PROCEDURE; HOWEVER, THERE WAS NO REPORTED ISSUE WITH THE RED62. THE PROCEDURE WAS COMPLETED USING A NEW RED43, A NEW RED62, 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 25106040 ↗MalfunctionAug 1, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED43 AND THE RED62 COAXIALLY TO THE TARGET LOCATION. THE PHYSICIAN COMPLETED TWO PASSES USING THE RED43. WHILE MANIPULATING THE RED62 AND RED43, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RED62 AND RED43 FRACTURED IN THE M1 SEGMENT OF THE MCA. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE WITHOUT SUCCESS. A NON-PENUMBRA BALLOON DEVICE WAS USED TO REMOVE THE FRACTURED SEGMENTS OF THE RED62 AND RED43 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED62, A NEW RED43, AND THE SAME BM96 RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22693149 ↗MalfunctionJun 13, 2025Fracture; 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 43 REPERFUSION CATHETER (RED43), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A 9FR NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE ADVANCING THE RED43 INTO THE RED62. THE PHYSICIAN ADVANCED THE RED62 CONTAINING THE RED43 AND A GUIDEWIRE TOGETHER INTO THE PROXIMAL FACE OF THE CLOT IN THE DISTAL M2 AND M3 ANGULAR BRANCH OF THE LEFT MCA. WHILE RETRACTING THE RED43 AND GUIDEWIRE, THE PHYSICIAN NOTICED THE RED43 HAD FRACTURED AND THE DISTAL SEGMENT OF THE RED43 REMAINED THE INTRACRANIAL VASCULATURE. IT WAS REPORTED THE DISTAL END OF THE RED43 WAS IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) AND THE PROXIMAL END OF THE RED43 WAS IN THE COMMON CAROTID. THE PHYSICIAN INITIATED ASPIRATION USING THE RED62 FOR APPROXIMATELY TWO MINUTES. THE RED62 WAS SLOWLY RETRACTED UNDER CONTINUOUS ASPIRATION WHILE MONITORING THE FLOW IN THE TUBING. THE PHYSICIAN REMOVED THE RED62 AND THE BMX96 WAS DOUBLE FLUSHED WITH SALINE. THE BMX96 WAS RETRACTED INTO THE DISTAL LEFT ICA A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205955 ↗MalfunctionMar 21, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA SHORT SHEATH, AND A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING THE RED43 THROUGH THE RED62 AND INTO THE TARGET LOCATION, THE STRAIN RELIEF OF THE RED43 FRACTURED. THE RED62 AND RED43 WERE REMOVED TOGETHER AS A SYSTEM. THE FRACTURED SEGMENT OF THE RED43 STRAIN RELIEF WAS REMOVED. THE RED43 AND RED62 WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO REPORTED ISSUE OR DAMAGE TO THE RED62. THE PROCEDURE WAS COMPLETED USING A NEW RED62 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665322 ↗MalfunctionMar 14, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED43 AND RED62 TOGETHER INTO THE TARGET LOCATION. NEXT, WHILE REMOVING THE RED43 OUT OF THE RED62 AND THE PHYSICIAN FRACTURED THE PROXIMAL END OF THE RED43. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE RED43. THE PHYSICIAN THEN USED THE RED62 TO REMOVE THE CLOT, AND 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 21610026 ↗MalfunctionJan 24, 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 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE RED43 AND RED62. TO MAKE THE NEXT PASS, THE RED43 AND RED62 WERE ADVANCED TOGETHER INTO THE TARGET LOCATION. THE PHYSICIAN WAS THEN RETRACTING THE RED43 OUT FROM THE RED62 TO BEGIN ASPIRATION USING THE RED62, BUT EXPERIENCED RESISTANCE AND FRACTURED THE RED43 AT THE MIDSHAFT. THEREFORE, THE RED43 AND RED62 WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW RED43. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO USE A NEW RED62. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233084 ↗MalfunctionNov 27, 2024Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS EXCESSIVELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED43, THE RED62, AND THE GUIDEWIRE TO THE CLOT. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE RED43. AFTER COMPLETING A PASS USING THE RED43 AND THE RED62, THE PHYSICIAN DECIDED TO REMOVE THE RED43 FROM THE PATIENT. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RED43 BECAME STUCK IN THE RED62. IT WAS NOTICED UNDER FLUOROSCOPY THAT THE RED43 WAS STRETCHED AND FRACTURED AT THE MID TO DISTAL LENGTH. THEREFORE, THE RED62, AND THE RED43 WERE REMOVED TOGETHER SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW RED43, A NEW RED62, AND A NEW GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20792258 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN 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 NEURON MAX 088 6F LONG SHEATH (NEURON MAX), A NON-PENUMBRA STENT RETRIEVER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE RED62, AND ONE PASS USING THE RED43. THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE OF 2A WAS ACHIEVED. THE PHYSICIAN THEN ATTEMPTED TO USE A STENT RETRIEVER; HOWEVER, THE STENT RETRIEVER COULD NOT ADVANCE PAST THE CLOT IN THE LEFT M2 SEGMENT. IT WAS REPORTED THAT A DISSECTION WAS NOTED IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND IT WAS PAST THE LEVEL OF NEURON MAX. THE PHYSICIAN PERFORMED BALLOON ANGIOPLASTY TO TREAT THE LEFT ICA DISSECTION WITH A BRISK FLOW RETURN TO THE ICA. A MTICI SCORE OF 2A WAS ACHIEVED. ON (B)(6) 2024, POST-PROCEDURE DAY ONE (POD1), THE LEFT ICA DISSECTION WAS CONSIDERED RESOLVED. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. ON (B)(6) 2024, THE PATIENT EXITED THE STUDY. ON
Patient problems: Vascular Dissection
MAUDE report 20764235 ↗InjuryOct 31, 2024Fracture; Fracture
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: Foreign Body In Patient
MAUDE report 20582843 ↗MalfunctionJul 15, 2024Fracture; Fracture
THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED43 REPERFUSION CATHETER (RED43), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE RED43. NEXT, AFTER REMOVING THE RED43 TO ASPIRATE THROUGH THE RED72, THE PHYSICIAN NOTICED THAT THE RED43 HAD FRACTURED AT THE DISTAL LOCATION. IT WAS REPORTED THAT THE DISTAL END OF THE RED43 WAS CONTAINED WITHIN THE BMX96 AND WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED WITH A NEW RED43. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19743486 ↗MalfunctionMay 14, 2024Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES IN THE TARGET LOCATION USING THE RED43 AND RED62. WHILE ATTEMPTING TO MAKE THE NEXT PASS, IT WAS REPORTED THE PHYSICIAN APPLIED MORE THAN USUAL FORCE TO THE COAXIAL SYSTEM AND THE DISTAL END OF THE RED43 KINKED WHILE INSIDE THE BMX96. WHILE RETRACTING THE RED43, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE RED43 AT THE DISTAL END. THE FRACTURED DISTAL SEGMENT OF THE RED43 WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW RED43, THE SAME RED62, 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 19315445 ↗MalfunctionApr 11, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE IN RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 6F (6F SELECT), A ROTATING HEMOSTASIS VALVE (RHV), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS NOT EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE NEURON MAX WAS PLACED WITHIN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING THE 6F SELECT AND THE GUIDEWIRE. THE 6F SELECT WAS REMOVED, AND THEN THE RED43 AND THE RED62 WERE ADVANCED TOGETHER AS A SYSTEM OVER THE GUIDEWIRE TO THE TARGET LOCATION. THE PHYSICIAN COMPLETED ONE PASS WHILE WITHDRAWING THE RED43 AND RED62 EXTRACTING MOST OF THE CLOT. THE RED43 AND THE RED62 WERE THEN REMOVED FOR FLUSHING. AFTER FLUSHING THE RED43 AND RED62, PRIOR TO RE-ADVANCING THE RED43 AND THE RED62 THROUGH THE RHV, THE RED43 WAS NOTED TO BE TWO TO THREE INCHES OUT OF RED62 AND INTO THE RHV. WHILE ATTEMPTING TO RE-ADVANCE THE RED43 AND THE RED62 THROUGH THE RHV, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE
Patient problems: Foreign Body In Patient
MAUDE report 19093706 ↗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 18481440 ↗MalfunctionAug 14, 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 BENCHMARK BMX96 ACCESS SYSTEM (BMX96), SENDIT DELIVERY DEVICE (SENDIT), PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), AND A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43). DURING THE PROCEDURE, THE BMX96 WAS ADVANCED OVER A GUIDEWIRE AND INTO THE MID TO LOW CERVICAL. NEXT, WHILE ADVANCING THE RED72 AND SENDIT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE BMX96 HAD FALLEN IN THE ARCH AS THE RED72 AND SENDIT WAS BEING ADVANCED FURTHER UP THE CAROTID T SEGMENT. THE PHYSICIAN THEN ADVANCED THE BMX96 OVER THE RED72 AND SENDIT TO THE MID CERVICAL BUT WAS STILL EXPERIENCING RESISTANCE ADVANCING THE RED72 AND SENDIT. THEREFORE, THE PHYSICIAN REMOVED THE SENDIT DEVICE AND SWITCHED TO A RED43. NEXT, WHILE ADVANCING THE RED43 AND GUIDEWIRE INTO THE RED72, THE PHYSICIAN NOTICED THE BMX96 WOULD FALL BACK INTO THE ARCH. THE BMX96 WAS ADVANCED BACK OVER THE RED72, RED43, AND GUIDEWIRE, BUT THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN THE BMX96. SUBSEQUENTLY, WHILE ATTEMPTING TO PULL BACK ON THE RED72, RED43, AND GUIDEWIRE, THE PHYSICIAN STILL EXPERIENCED RESISTA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17546980 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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