Penumbra recalls RED 68 Reperfusion Catheters with potential fracture risk due to manufacturing issues. Affected units include specific UDI and lot numbers.
Due to manufacturing issues, reperfusion catheters may fractures
Penumbra is recalling its RED 68 Reperfusion Catheter (REF: RED68KIT) because manufacturing issues may cause the catheters to fracture. This could lead to serious complications during medical procedures.
The catheters may fracture due to manufacturing defects. If a catheter fractures during use, it could cause serious complications like bleeding or tissue damage in patients.
Healthcare professionals using the Penumbra RED 68 Reperfusion Catheter for medical procedures are likely affected. Patients receiving this catheter during treatment are at risk if the device fractures.
Check for the UDI code 00815948024113 and lot numbers H00008699, H00008701, H00008702, H00008703, or C00020038 on the catheter packaging or label.
Inspect the catheter for signs of fracture or damage before use. If fractured, stop using it immediately.
Due to manufacturing issues, the Penumbra RED 68 Reperfusion Catheter may fracture, which could cause serious complications during medical procedures.
Check the UDI code and lot numbers on the catheter packaging. If it matches the affected units, stop using it and contact Penumbra for guidance.
Affected units have UDI: 00815948024113 and lot numbers H00008699, H00008701, H00008702, H00008703, or C00020038.
We’ve drafted a message you can send Penumbra to request your refund or repair — edit it as you like.
Subject: Recall Z-2770-2026 — Penumbra Penumbra Hello, I own a Penumbra that is covered by recall Z-2770-2026 from Penumbra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
