Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration… — Class I medical device recall Z-0850-2021
Terminated recall by Penumbra Inc., reported 2021-01-27, distributed nationwide. The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pre
| Recall number | Z-0850-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Penumbra Inc., Alameda, CA, United States |
| Recall initiated | 2020-12-15 |
| Classified | 2021-01-18 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2024-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CL, CO, CR, DO, HK, IL, JP, KR, LB, MY, NP, NZ, OM, PA, SA, SG, TH, TW, VN, ZA |
| Quantity | 0 catheters |
| UPC / GTIN / UDI-DI | 00815948021594 |
| Model numbers | 5MAXJET7L138KIT |
Product
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) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0850-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.