Medical DeviceJul 29, 2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall — FDA Z-2770-2026
Due to manufacturing issues, reperfusion catheters may fractures
Class IIFDA: OngoingPenumbra, Inc.
Recall history in this database
Classification mix: Class I: 4, Class II: 1.
Medical DeviceJan 27, 2021
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT recall — FDA Z-0849-2021
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…
Class IFDA: TerminatedPenumbra Inc.
Medical DeviceJan 27, 2021
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter recall — FDA Z-0848-2021
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…
Class IFDA: TerminatedPenumbra Inc.
Medical DeviceJan 27, 2021
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow recall — FDA Z-0851-2021
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…
Class IFDA: TerminatedPenumbra Inc.
Medical DeviceJan 27, 2021
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF recall — FDA Z-0850-2021
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…
Class IFDA: TerminatedPenumbra Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Penumbra, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.