Penumbra System 5MAXJET7-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548019901), received between Jan 4, 2019 and Aug 29, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE JET7 BROKE WHILE BEING ADVANCED THROUGH THE NEURON MAX. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944942 ↗
• MalfunctionJan 15, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE JET7 BROKE AROUND ITS PROXIMAL TO MID SHAFT AREA; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249460 ↗
• MalfunctionJan 4, 2019Fracture; 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 JET7 KIT. THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) INTO THE TARGET VESSEL AND WAS UNABLE TO REACH THE CLOT. THE JET7 WAS THEREFORE RETRACTED. AS THE JET7 WAS BEING RETRACTED, THE PHYSICIAN FELT RESISTANCE AND NOTICED THAT THE JET7 HAD BECOME STUCK IN THE OPHTHALMIC ARTERY. AS THE PHYSICIAN CONTINUED TO RETRACT, THE JET7 FRACTURED AT THE PROXIMAL HALF WHILE STILL WITHIN THE PATIENT. THE JET7 WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219961 ↗