# FDA recall Z-0849-2021

> **Penumbra Inc.** · Class I · device recall initiated 2020-12-15.

## Product

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 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.

## Distribution

Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S  (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.

## Key facts

- **Recall number:** Z-0849-2021
- **Recalling firm:** Penumbra Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-15
- **Report date:** 2021-01-27
- **Termination date:** 2024-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0849-2021

## Citation

> AI Analytics. FDA recall Z-0849-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0849-2021. Source: US FDA. Licensed CC0.

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