FDA Medical Device Recalls (openFDA)
Penumbra, Inc.: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Recall number
- Z-2770-2026
- Recalling firm
- Penumbra, Inc.
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Status
- Open, Classified
- Initiated
- 2026-06-03
- Posted
- 2026-07-21
- Terminated
- not on file
- Reason
- Due to manufacturing issues, reperfusion catheters may fractures
- 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 notifications@penumbrainc.com. 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- 510(k) numbers
- ["K211411"]
- PMA numbers
- not on file
- Product code
- NRY
- Firm FEI
- 3013758550
- Firm city
- Livermore
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28