RED 72 RED72-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00815948023918), received between Oct 8, 2021 and Sep 15, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777516 ↗
• MalfunctionJan 23, 2026Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT WHILE INTRODUCING THE RED72 BEFORE ANY PASSES WERE MADE, IT BECAME STUCK IN THE OPHTHALMIC SEGMENT OF THE ICA AND COULD NOT BE ADVANCED DISTALLY. WHILE ATTEMPTING TO RETRACT THE RED72 WITHIN THE NEURON MAX, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE RED72 BECAME STRETCHED AND FRACTURED ON THE DISTAL LENGTH. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE RED72, NEURON MAX, AND GUIDEWIRE TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER 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 24171065 ↗
• MalfunctionDec 18, 2025Fracture; Stretched; Fracture; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A STENT RETRIEVER, AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET LOCATION USING THE RED72 AND THE STENT RETRIEVER. WHILE REMOVING THE RED72 FROM THE PATIENT, THE PHYSICIAN FOUND THAT IT WAS STRETCHED AND FRACTURED ON THE DISTAL LENGTH. THE DISTAL SEGMENT OF THE RED72 WAS REMOVED WHILE REMOVING THE STENT RETRIEVER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED72 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 23845539 ↗
• InjuryDec 15, 2025Fracture; Physical Resistance/Sticking; Fracture; 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 PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA LONG SHEATH, A NON-PENUMBRA MICROCATHETER, A STENT RETRIEVER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER PERFORMING TWO PASSES IN THE TARGET LOCATION USING THE ACE68, THE OCCLUSION OPENED SLIGHTLY. THE PHYSICIAN THEN DECIDED TO REMOVE THE ACE68 AND EXCHANGE IT FOR A RED72. WHILE PERFORMING THE NEXT PASS USING THE RED72, THE PHYSICIAN ATTEMPTED TO ASPIRATE AND RETRACT THE RED72; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE RED72 WAS NOT MOVING. THE PHYSICIAN MADE ANOTHER ATTEMPT TO RETRACT THE RED72 AND FRACTURED IT ON THE DISTAL LENGTH WITHIN THE MCA. ATTEMPTS WERE MADE TO REMOVE THE FRACTURED SEGMENT OF THE RED72 USING A SNARE DEVICE, THEN A STENT RETRIEVER, AND BY ADVANCING THE LONG SHEATH CLOSE TO THE TARGET LOCATION, WITHOUT SUCCESS. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO REMOVE THE FRACTURED SEGMENT OF THE RED72, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. THE PHYSICIAN THEN PERFORMED A LEFT SIDE ANGIOGRAM AND REPORTED THAT THE FLOW WAS GOOD, BUT THE FL

  Patient problems: Foreign Body In Patient

  MAUDE report 23812490 ↗
• MalfunctionApr 28, 2025Fracture; Unraveled Material; Physical Resistance/Sticking; Fracture; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A MICROCATHETER, AND A .35 GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE RED72 THROUGH THE NEURON MAX USING THE MICROCATHETER AND GUIDEWIRE, THE RED72 BECAME STUCK IN THE OPHTHALMIC ARTERY. WHILE ATTEMPTING TO PULL THE RED72 BACK, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE MID-SHAFT OF THE RED72 WAS STRETCHED AND UNRAVELED. THEREFORE, THE NEURON MAX CONTAINING THE DAMAGED RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND THE SAME NEURON MAX TO MAKE THREE PASSES. IT WAS REPORTED THAT TICI 2B WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921788 ↗
• MalfunctionOct 4, 2024Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE RETRACTING THE RED72 DURING THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. THE RED72 WAS THEN FOUND TO BE STRETCHED AND FRACTURED AT THE PROXIMAL END. THEREFORE, THE NEURON MAX AND THE RED72 WERE REMOVED TOGETHER, AND THE RED72 WAS THEN REMOVED FROM THE NEURON MAX. THE PROCEDURE WAS COMPLETED WITH THE SAME NEURON MAX AND A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375275 ↗
• MalfunctionJan 19, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A TOTAL OCCLUSION USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A STENT RETRIEVER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS WITH THE RED72 AND THE STENT RETRIEVER. WHILE ADVANCING THE STENT RETRIEVER THROUGH THE RED72 DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE BUT CONTINUED TO COMPLETE THE PASS. WHILE REMOVING THE RED72 AND THE STENT RETRIEVER FROM THE PATIENT, THE STENT RETRIEVER BECAME CAUGHT INSIDE THE RED72. AFTER REMOVAL, THE PHYSICIAN FOUND THAT THE RED72 WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A 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 18545257 ↗
• MalfunctionJan 16, 2024Leak/Splash; Leak/Splash

  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 NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 THROUGH THE NEURON MAX AND INTO LOCATION THEN INITIATED ASPIRATION. SUBSEQUENTLY, THE PHYSICIAN FOUND THAT BLOOD WAS LEAKING AT THE PROXIMAL END OF THE RED72, NEAR THE HUB. THE PHYSICIAN THEN USED OPSITE WOUND DRESSINGS TO SEAL THE LEAK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER TWO PASSES USING THE SAME RED72. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522220 ↗
• MalfunctionDec 4, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE RED72 THROUGH THE DISTAL LENGTH OF THE NEURON MAX DURING THE FIRST PASS. THE PHYSICIAN CONTINUED RETRACTING THE RED72 AND NOTICED THAT THE DISTAL LENGTH OF THE RED72 HAD FRACTURED INSIDE THE NEURON MAX. THEREFORE, THE NEURON MAX CONTAINING THE FRACTURED RED72 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) 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 18260524 ↗
• MalfunctionNov 10, 2023Fracture; 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 NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RED72 OVER THE MICROCATHETER AND THE GUIDEWIRE, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN CONTINUED TO EXPERIENCE RESISTANCE AS THE RED72 WAS ADVANCED FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RED72, MICROCATHETER, AND GUIDEWIRE. WHILE REMOVING THE RED72, THE PHYSICIAN ALSO EXPERIENCED RESISTANCE AND UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE RED72 WAS STRETCHED AND FRACTURED MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND THE SAME SHEATH, MICROCATHETER, AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116516 ↗
• MalfunctionApr 27, 2023Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE RED72 INTO THE TARGET LOCATION TO MAKE THE FIRST PASS, THE PHYSICIAN NOTICED A LEAK AT THE PROXIMAL END OF THE RED72. THEREFORE, THE RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RED72, THE SAME 3MAXC, 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 16828472 ↗
• MalfunctionApr 19, 2023Break; Stretched; Physical Resistance/Sticking; Break; Stretched; 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 NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RED72 OVER THE MICROCATHETER AND THE GUIDEWIRE. WHILE RETRACTING THE RED72 AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN. SUBSEQUENTLY, AFTER REMOVAL OF THE RED72, THE PHYSICIAN NOTICED THAT IT WAS BROKEN AND STRETCHED AT THE DISTAL END. THEREFORE, THE RED72 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), THE SAME NEURON MAX, THE SAME MICROCATHETER, 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 16773583 ↗
• MalfunctionJan 13, 2023Break; Break

  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) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS AT THE TARGET LOCATION USING THE RED72. SUBSEQUENTLY, WHILE REMOVING THE RED 72, THE PHYSICIAN BROKE THE RED72 AT THE HUB TRANSITION POINT. THEREFORE, THE RED72 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND THE SAME BENCHMARK MAX 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 16159765 ↗
• MalfunctionDec 2, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE 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. SUBSEQUENTLY, WHILE RETRACTING THE RED72, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE RED72 FRACTURED INSIDE THE PATIENT. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE REMAINING PIECE OF THE RED72. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING AND RETRACTING THE RED72. THE PROCEDURE WAS COMPLETED USING A RED62 AND A BENCHMARK BMX96 ACCESS SYSTEM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908295 ↗
• MalfunctionAug 26, 2022Crack; Leak/Splash; Crack; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX 96) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RED72 INTO THE BMX 96 FOR THE FIRST PASS, THE PROXIMAL END OF THE RED72 CRACKED AND WAS LEAKING. THEREFORE, THE RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RED72 AND THE SAME BMX 96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303009 ↗
• MalfunctionJul 22, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, WHILE ADVANCING THE RED72 TO THE TARGET VESSEL, THE PHYSICIAN FRACTURED THE RED72 MIDSHAFT. THEREFORE, THE RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME VELOCITY AND A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086421 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, WHILE INITIALLY ADVANCING THE RED72 TO THE TARGET VESSEL, THE PHYSICIAN FRACTURED THE RED72 MID-SHAFT. THE PHYSICIAN THEN RETRACTED THE RED72 AND UPON REMOVAL, THE PHYSICIAN FOUND THAT THE FRACTURED DISTAL END OF THE RED72 WAS IN THE ICA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE FRACTURED PIECE OF RED72. THE PROCEDURE WAS COMPLETED USING THE SAME VELOCITY AND A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070652 ↗
• MalfunctionOct 8, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA STENT RETRIEVER, AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS USING THE ADAPT TECHNIQUE WITH A RED72. THE PHYSICIAN MADE THE SECOND AND THIRD PASS USING A STENT RETRIEVER WITH THE RED72. SUBSEQUENTLY, THE STENT RETRIEVER WAS RETRACTED BACK INTO THE RED72, THE PHYSICIAN THEN REMOVED BOTH THE STENT RETRIEVER AND RED72 AS A UNIT AND NOTICED THE DISTAL THIRD OF THE RED72 TO BE ACCORDIONED ON THE BACK TABLE. THEREFORE, THE RED72 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITH THE SAME VELOCITY, STENT RETRIEVER, AND NEURON MAX. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ACHIEVE REPERFUSION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598762 ↗