Z-2770-2026Class II

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Name: Z-2770-2026 Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Creator: Penumbra, Inc.
Published: 2026-06-03
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2026-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Penumbra, Inc. began a recall of Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT on 2026-06-03. FDA classified it as Class II and gives the reason as "Due to manufacturing issues, reperfusion catheters may fractures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2770-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-03
Posted: 2026-07-21
Recalling firm: Penumbra Inc.
Product: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: Due to manufacturing issues, reperfusion catheters may fractures
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On June 2, 2026, Penumbra issued a Urgent Medical Device Recall Notification to affecte consignees via FedEx. Penumbra asked consignees to take the following actions: 1. Review inventory and remove affected units from inventory and place in quarantine for return. 2.Complete and return the response form to [email protected]. Your Penumbra representative will work with you directly to arrange return and credit of affected devices. If you do not have any affected product, please still complete the response form and return. 3. Share recall notification with all users of the product within your facility.
Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Product codes and lots: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2770-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2770-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-21

Product code NRY

K211411Class IIPenumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc. / cleared 2021-07-01

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)