Benchmark MAX SystemRecalls & reported problems across all models
Penumbra, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 13 models of Benchmark MAX System by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Nov 25, 2020 and Nov 21, 2025 — classified as 8 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Benchmark MAX System problems
Device problems
- Fracture17
- Physical Resistance/Sticking14
- Break7
- Material Deformation7
- Adverse Event Without Identified Device or Use Problem4
- Failure to Advance2
- Connection Problem1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient5
- Vascular Dissection3
- Foreign Body In Patient2
- Hematoma2
- Perforation of Vessels2
- Foreign Body Embolism1
- Ischemia Stroke1
Benchmark MAX System models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Benchmark MAX System BMX9690BER125-ACATHETER, PERCUTANEOUS11 reports
- Benchmark MAX System BMX9690SIM125-ACATHETER, PERCUTANEOUS5 reports
- Benchmark MAX System BMX9680BER105-ACATHETER, PERCUTANEOUS4 reports
- Benchmark MAX System BMX9690MSIM125-ACATHETER, PERCUTANEOUS3 reports
- Benchmark MAX System BMX7F95-ACATHETER, PERCUTANEOUS3 reports
- Benchmark MAX System BMX7F105-ACATHETER, PERCUTANEOUS2 reports
- Benchmark MAX System BMX96100-ACATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX9690MBER125-ACATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX96100SIM125-ACATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX7F105M-ACATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX7F95M-ACATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX9690SIM125-BCATHETER, PERCUTANEOUS1 report
- Benchmark MAX System BMX9690BER125-BCATHETER, PERCUTANEOUS1 report
Recent Benchmark MAX System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Fracture; Fracture
THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 81 ACCESS SYSTEM (BMX81). AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN WAS REMOVING THE BMX81 FROM THE PATIENT AND NOTICED THE BMX81 HAD FRACTURED. THEREFORE, THE PHYSICIAN PLACED A GUIDEWIRE THROUGH THE FRACTURED BMX81 AND ADVANCED A NEURON SELECT CATHETER 5F (5F SELECT) OVER THE GUIDEWIRE AND THROUGH THE FRACTURED BMX81. THE FRACTURED BMX81 WAS THEN REMOVED TOGETHER WITH THE 5F SELECT AND GUIDEWIRE AS A UNIT. IT WAS REPORTED THAT THE ENTIRE FRACTURED BMX81 WAS REMOVED, AND NO PART OF THE BMX81 WAS LEFT IN THE PATIENT. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623426 ↗InjurySep 17, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE COMMON CAROTID ARTERY (CCA) USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81), A NON-PENUMBRA SHEATH (7F), A NON-PENUMBRA ASPIRATION CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE RADIAL ARTERY USING THE SHEATH. WHILE ADVANCING THE BMX81 THROUGH THE SHEATH OVER THE GUIDEWIRE TOWARD THE SUBCLAVIAN ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS NOTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE THE BMX81 TO THE CCA. THE PHYSICIAN THEN ADVANCED THE ASPIRATION CATHETER THROUGH THE BMX81 OVER THE GUIDEWIRE TO THE TARGET LOCATION AND PERFORMED ASPIRATION. AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE ASPIRATION CATHETER. WHILE REMOVING THE BMX81 FROM THE PATIENT'S BODY, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE BMX81 BECAME DAMAGED AT THE MIDSHAFT OUTSIDE OF THE PATIENT'S BODY. THE PHYSICIAN THEN USED A HEMOSTAT TO CLAMP THE BMX81 AND THE SHEATH TOGETHER TO PREVENT AIR FROM ENTERING. WHILE SLOWLY REMOVING THE BMX81 AND THE SHEATH USING THE HEMOSTAT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE RADIAL ARTERY CAME OUT ALONG WITH THE DAMAGED BMX81. THE PHYSICIAN HELD
Patient problems: Perforation of Vessels
MAUDE report 23073868 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81) AND A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS IN THE TARGET LOCATION USING THE RED62. AFTER THE PASS, THE RED62 WAS REMOVED TO BE FLUSHED, AND THE PHYSICIAN NOTICED THE BMX81 DISTAL END BECAME OCCLUSIVE TO THE VESSEL AND DISSECTED THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN PLACED A STENT IN THE CAROTID. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43).
Patient problems: Vascular Dissection
MAUDE report 22946461 ↗MalfunctionMay 27, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY (CCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 AND THE GUIDEWIRE INTO THE RIGHT CCA. THE BMX96 WAS TORQUED IN THE COMMON ILIAC ARTERY AND BECAME DAMAGED. THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE THROUGH THE BMX96. THE BMX96 THEN FRACTURED UPON RETRACTION BUT WAS STUCK IN THE SHEATH. THE PHYSICIAN THEN DECIDED TO REMOVE THE BMX96 AND THE SHEATH TOGETHER FROM THE PATIENT. THE PHYSICIAN CLAMPED THE BMX96 UPON REMOVING IT WITH THE SHEATH AND MADE ANOTHER FRACTURE IN ORDER TO MAINTAIN WIRE ACCESS. THE PROCEDURE WAS COMPLETED USING A NEW BMX96 AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092256 ↗MalfunctionFeb 21, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND A NEURON SELECT CATHETER 6F (6F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 6F SELECT CATHETER IN THE CAROTID ARTERY, THE PHYSICIAN NOTICED THE DISTAL LENGTH OF THE 6F SELECT HAD FRACTURED IN THE FEMORAL ARTERY UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL PORTION OF THE 6F SELECT OUT FROM THE BMX96. THE PHYSICIAN THEN ADVANCED THE BMX96 FROM THE RIGHT FEMORAL ARTERY TO THE LEFT FEMORAL ARTERY AND USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE FRACTURED 6F SELECT. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND IS RESCHEDULED FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437083 ↗InjuryJan 23, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TRANSVERSE SIGMOID SINUS USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81), A STENT, AND A GUIDEWIRE. DURING THE PROCEDURE, THE BMX81 WAS ADVANCED INTO THE VESSEL. NEXT, WHILE ADVANCING A STENT THROUGH THE BMX81 INTO THE VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE STENT BECAME STUCK PARTIALLY OUTSIDE OF THE BMX81. WHILE ATTEMPTING TO PUSH THE STENT OUT WITH THE GUIDEWIRE, THE PHYSICIAN FRACTURED THE BMX81 AT THE DISTAL END. THEREFORE, THE PROXIMAL PORTION OF THE BMX81 WAS REMOVED. A SNARE WAS ADVANCED TO THE VESSEL TO REMOVE THE FRACTURED PORTION OF THE BMX81; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE DISTAL PORTION OF THE BMX81 WAS LEFT IN THE RIGHT CAROTID ARTERY. THE PROCEDURE HAD ENDED AT THIS POINT. LATER, THE PATIENT EXPIRED DUE TO OTHER COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 21218354 ↗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 20582859 ↗MalfunctionOct 4, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81) AND A NON-PENUMBRA SHEATH (7FR). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL THROUGH THE RIGHT RADIAL ARTERY AND ADMINISTERED MEDICATIONS (VERAPAMIL, NITROGLYCERIN, AND HEPARIN). AFTER PLACING THE SHEATH, THE BMX81 WAS ADVANCED INTO THE VESSEL. WHILE ADVANCING THE BMX81 INTO THE VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO REMOVE THE BMX81. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE BMX81 HAD FRACTURED ON THE DISTAL END NEAR THE MARKERBAND. IT WAS NOTED THAT THE TIP OF THE BMX81 HAD MOVED INTO AN ADJACENT ARTERY. AFTER ASSESSING WITH A SECOND PHYSICIAN, IT WAS DECIDED TO LEAVE THE FRACTURED TIP IN THE PATIENT''S VESSEL. THE PROCEDURE WAS COMPLETED WITH A NEW BMX81 WITH RIGHT FEMORAL ACCESS.
Patient problems: Foreign Body In Patient
MAUDE report 20377689 ↗MalfunctionSep 4, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 INTO THE AORTIC ARCH. WHILE PERFORMING AN INJECTION, THE PHYSICIAN FRACTURED THE BMX96 AT THE HUB. THEREFORE, THE BMX96 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20138525 ↗MalfunctionJul 9, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA CATHETER, AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED AN ANGIOPLASTY AND CAROTID STENT. NEXT, WHILE ADVANCING A BMX96 TO THE TARGET VESSEL, THE BMX96 FRACTURED ON THE PROXIMAL END. THEREFORE, THE BMX96 WAS REMOVED. THE PROCEDURE WAS ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19703384 ↗MalfunctionMar 19, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), NEURON SELECT CATHETER 6F (6F SELECT), A GUIDEWIRE AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE DILATOR INTO THE BMX96. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE 6F SELECT INTO THE BMX96 BUT WOULD STILL EXPERIENCE RESISTANCE. SUBSEQUENTLY, UPON INSPECTING THE BMX96, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THE DISTAL END OF THE BMX96 WAS FRACTURED. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE WITH ANOTHER SELECT CATHETER THROUGH THE FRACTURED BMX96 AND REMOVED THE ENTIRE BMX96. THE PROCEDURE WAS COMPLETED USING A NEW BMX96 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 18937996 ↗InjuryMar 14, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BMX96 ACCESS SYSTEM (BMX96), BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARK), AND GUIDEWIRES. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE GUIDEWIRES WERE PLACED IN THE PETROUS PORTION OF THE ICA. DURING THE PROCEDURE, WHILE ADVANCING THE BMX96 TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE BMX96. THE PHYSICIAN THEN VISUALIZED UNDER FLUOROSCOPY THAT THE MIDSHAFT OF THE BMX96 WAS FRACTURED; HOWEVER, THE BMX96 WAS STILL INTACT. THEREFORE, THE BMX96 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK. WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE. THE BENCHMARK WAS REMOVED. A SECOND BENCHMARK WAS ADVANCED INTO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO REPOSITION THE BENCHMARK. WHILE RETRACTING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE, THE SECOND BENCHMARK WAS REMOVED. IT WAS REPORTED SHEATHS WERE NOT BEING USED AND THAT MAY HAVE CONTRIBUTED TO THE DAM
Patient problems: Hematoma
MAUDE report 18909266 ↗MalfunctionAug 24, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE COMMON CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH (8F), AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT''S ANATOMY WAS TORTUOUS AND THE PHYSICIAN HAD DIFFICULTY ACCESSING THE VESSEL USING THE BMX96. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 OVER THE 6F SELECT TO THE TARGET LOCATION AGAINST RESISTANCE. WHILE RETRACTING THE 6F SELECT FROM THE BMX96, THE PHYSICIAN EXPERIENCED RESISTANCE, AND NOTICED UNDER FLUOROSCOPY THE BMX96 APPEARED TO BE FRACTURED NEAR THE DISTAL END. THEREFORE, THE PHYSICIAN PULLED OUT THE PROXIMAL PORTION OF THE BMX96 FROM THE PATIENT AND THE DISTAL PORTION WAS REMOVED VIA VASCULAR SURGERY. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED PULLING OUT THE PROXIMAL PORTION OF THE BMX96 FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17620129 ↗MalfunctionJul 18, 2023Break; Break
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), ANTERIOR CEREBRAL ARTERY (ACA), AND MIDDLE CEREBRAL ARTERY (MCA), USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE BMX96 HAD BROKEN. SUBSEQUENTLY, WHILE ATTEMPTING TO REMOVE THE BMX96, IT BROKE INTO THREE PIECES. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BROKEN PIECES OF THE BMX96. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17347299 ↗MalfunctionJul 3, 2023Break; Difficult to Advance; Physical Resistance/Sticking; Break; Difficult to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE BMX96 THROUGH THE RIGHT RADIAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN CONTINUED TO ADVANCE THE BMX96 AGAINST RESISTANCE AND WAS ABLE TO GET THE BMX96 INTO THE AORTIC ARCH. SUBSEQUENTLY, THE BMX96 WOULD NOT ADVANCE ANY FURTHER AND THE PHYSICIAN DECIDED TO ABORT THE RADIAL ACCESS AND REMOVE THE BMX96. WHILE RETRACTING THE BMX96, THE PHYSICIAN AGAIN EXPERIENCED RESISTANCE AND FRACTURED THE PROXIMAL END OF THE BMX96. THEREFORE, THE PHYSICIAN USED A CLAMP TO REMOVE THE REMAINING EXPOSED BMX96 AND UPON PULLING IT FURTHER, THE DISTAL END OF THE BMX96 HAD BROKEN INTO TWO SEPARATE PIECES. THE PHYSICIAN THEN OBTAINED FEMORAL ACCESS AND USED A SNARE DEVICE TO REMOVE THE BROKEN DISTAL END OF THE BMX96. THE PROCEDURE WAS COMPLETED USING A NEW BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17252277 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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