Penumbra System J7XKIT132-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948021273), received between Aug 5, 2020 and Oct 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K191946); they may or may not involve this specific model.

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.

Recalls naming this device

1. Dec 15, 2020Class ITerminated

   The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.

   Z-0851-2021 · Root cause: Process design · Recall details · FDA record ↗

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.

• MalfunctionOct 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A MAX DELIVERY DEVICE (MAX DEVICE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE MAX DEVICE; HOWEVER, THE GUIDEWIRE WAS STILL ABLE TO BE USED WITH THE MAX DEVICE. IT WAS ALSO REPORTED THAT THE MAX DEVICE BECAME STUCK UPON REMOVAL FROM THE JET7 AND FELT LIKE A SPRING. THE PHYSICIAN COMPLETED THE PROCEDURE USING THE SAME GUIDEWIRE AND MAX DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10693592 ↗
• MalfunctionAug 26, 2020Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A MAX DELIVERY DEVICE (MAX DEVICE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE MAX DEVICE; HOWEVER, THE GUIDEWIRE WAS STILL ABLE TO BE USED WITH THE MAX DEVICE. IT WAS ALSO REPORTED THAT THE MAX DEVICE BECAME STUCK UPON REMOVAL FROM THE JET7 AND FELT LIKE A SPRING. THE PHYSICIAN COMPLETED THE PROCEDURE USING THE SAME GUIDEWIRE AND MAX DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10456797 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 THROUGH THE NEURON MAX AND COMPLETED ONE PASS. SUBSEQUENTLY, AFTER COMPLETION OF THE SECOND PASS, THE PHYSICIAN RETRACTED THE JET7 WITH THROMBUS BACK INTO THE NEURON MAX AND THE DISTAL END OF THE JET7 STRETCHED. THEREFORE, THE JET7 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 10368318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191946. One submission often covers many models, so check the product and lot details in each record.

• Z-0848-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 X
• Z-0850-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex)
• Z-0849-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is