Z-0850-2021Class I

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra...

Name: Z-0850-2021 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra...
Creator: Penumbra Inc.
Published: 2020-12-15
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2020-12-15 / Terminated / root cause: manufacturing process

FDA source

Penumbra Inc. began a recall of Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex... on 2020-12-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0850-2021
Classification: Class I
Status: Terminated
Initiated: 2020-12-15
Posted: 2021-01-18
Terminated: 2024-05-14
Recalling firm: Penumbra Inc.
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.
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 12/15/2020, the firm posted a press release (https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf) and issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter via FedEx informing customers that all configurations of their reperfusion catheters may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death. Customers are instructed to: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific catalog numbers listed above. 3. Remove all units from inventory and place them in quarantine for return to Penumbra, Inc. 4. Complete and return the attached product identification / return form within 3 business days. 5. Continue to report adverse events and quality problems experienced with the use of this product. Adverse events and quality problems may be reported to FDA s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. For more information, please see https://www.accessdata.fda.gov/scripts/medwatch/index.cfm. The Recalling Firm will contact customers directly to arrange return of affected units and replace/refund returned product. If customers have any questions or concerns, they can contact the Recalling Firm's Customer Service ([email protected] or 1.888.272.4606), available Monday - Friday 7:30 AM to 4:00 PM PST, or their sales representative.
Quantity in commerce: 0 catheters
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.
Product codes and lots: Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7L138KIT UDI Code: 00815948021594 Lot Number Range: F97123 thru F98981 Note - none were distributed

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0850-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-18
Z-0849-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-18
Z-0850-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-18
Z-0851-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-18

Product code NRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)