Penumbra System 5MAXJET7L138KIT-BRecalls & reported problems
Penumbra, Inc. · JET7 Kit, 138 cm, no CE · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Dec 15, 2020Terminated
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-0850-2021 · Root cause: Process design · FDA record ↗
Other Catheter, Thrombus Retriever devices
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- EMBOTRAP ET309537Neuravi Limited · Catheter, Thrombus Retriever13 deaths177 reports
- ACE 5MAXACE068KITPenumbra, Inc. · CATHETER, THROMBUS RETRIEVER170 reports
- Embotrap ET009533Neuravi Limited · Catheter, Thrombus Retriever16 deaths153 reports
- Penumbra System 5MAXACE132Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER3 deaths112 reports
- Penumbra System 5MAXJET7KIT-APenumbra, Inc. · Catheter, Thrombus Retriever1 death94 reports
- Trevo XP 90185Stryker Corporation · CATHETER, THROMBUS RETRIEVER1 recall1 death40 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.