Penumbra System J7XBKIT132-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948023260), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

4 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A MAX DELIVERY DEVICE (MAX DEVICE), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). AND A GUIDE WIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. NEXT, WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN ADVANCED THE RED72 AND MAX DEVICE TO THE TARGET LOCATION. SUBSEQUENTLY, WHILE REMOVING THE MAX DEVICE TO ATTACH THE TUBING TO THE RED72 FOR ASPIRATION, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN STRETCHED AND BROKE THE MAX DEVICE IN TWO PIECES AT THE DISTAL END. THEREFORE, THE RED72 WAS REMOVED CONTAINING BOTH PIECES OF THE MAX DEVICE. AFTER REMOVAL, IT WAS NOTED THAT THE RED72 WAS ALSO STRETCHED AND FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW RED72 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 16088134 ↗

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-0851-2021 · Dec 15, 2020 · Terminated
  Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex te
• 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