Penumbra, Inc.: Catheter, Thrombus Retriever
Recall Summary Penumbra, Inc. is recalling its System RED 68 Reperfusion Catheter (model RED68KIT) worldwide due to manufacturing defects that may cause the catheter to fracture during use. This medical device is used to remove blood clots and was distributed across the United States, U.S. territories, and multiple countries including Canada, Mexico, Brazil, and several others in Asia, the Middle East, and Latin America. The recall is classified as Class II, indicating a potential health risk.
- Recalling firm
- Penumbra, Inc.
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Reason
- Due to manufacturing issues, reperfusion catheters may fractures
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5e3033ee-d00a-44e1-8aa9-817235abaa8e