🟡
Class II
May cause reversible problems
🩺Dispositivo médico#Z-2770-2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
What happened?
Due to manufacturing issues, reperfusion catheters may fractures
What should I do now?
- 1Check the lot number on your product packaging.
- 2If you have it, stop using it.
- 3Return it to your pharmacy or store for a refund.
- 4If you already used it and feel unwell, see your doctor immediately.
- 5Report adverse effects to the FDA: 1-800-FDA-1088.
- Company
- Penumbra, Inc.
- Status
- Ongoing
- Report date
- 2026-07-29
- Initiated
- 2026-06-03
- 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.
- Quantity
- N/A
This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.