Penumbra System 5MAXJET7B-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948023239), received between Nov 24, 2021 and Jun 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX INTO THE PATIENT. THE PHYSICIAN THEN ADVANCED THE JET7 THROUGH THE NEURON MAX AND INTO THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER AND THE GUIDEWIRE. THE NON-PENUMBRA MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED. NEXT, THE PHYSICIAN BEGAN TO ASPIRATE THE THROMBUS AND PUSHED AND PULLED THE JET7 BACK. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE PULLING THE JET7 AND SUBSEQUENTLY, THERE WAS A FREE FLOW OF BLOOD BACK INTO THE TUBING. THE PHYSICIAN THEN RETRACTED THE JET7. UPON REMOVAL, THE PHYSICIAN FOUND THAT APPROXIMATELY 20-25 CENTIMETERS OF THE DISTAL END OF THE JET7 WAS STILL INSIDE THE PATIENT. THEREFORE, THE PHYSICIAN REMOVED THE BROKEN PART OF THE JET7 FROM THE PATIENT USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) 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 14802791 ↗
• MalfunctionNov 24, 2021Break; Physical Resistance/Sticking; Suction Failure; Break; Physical Resistance/Sticking; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, WHILE ADVANCING THE JET7 THROUGH THE NEURON MAX TO THE TARGET LOCATION FOR THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. ONCE THE JET7 WAS AT THE TARGET LOCATION, ASPIRATION WAS INITIATED; HOWEVER, THE ASPIRATION FAILED. SUBSEQUENTLY, IT WAS NOTICED THAT THE DISTAL END OF THE JET7 WAS BROKEN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE JET7. WHILE REMOVING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE; HOWEVER, THE JET7 WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW JET7, THE SAME NEURON MAX AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872441 ↗