Terumo recalls Angio-Seal Evolution Vascular Closure Device (Cat. No. C610135) due to potential failure in use. Affected units may not function as intended and should not be used.
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Terumo is recalling Angio-Seal Evolution Vascular Closure Devices with specific serial numbers because they were released before full quality checks were completed. These devices might not work properly and could cause harm if used.
The devices were released before all required quality checks were completed. Even though they are sterile, they may not function as intended during medical procedures, potentially causing complications.
Patients who received the Angio-Seal Evolution Vascular Closure Device with serial numbers 5980075 or 5980077 are affected. Medical professionals using these devices for vascular procedures are at risk.
Check for the product name 'Angio-Seal Evolution Vascular Closure Device' and serial numbers 5980075 or 5980077. These devices were sold by Terumo Medical Corp.
Immediately stop using the Angio-Seal Evolution Vascular Closure Device with serial numbers 5980075 or 5980077.
The devices were released before all required quality checks were completed, so they may not function as intended.
Immediately stop using it and contact Terumo Medical Corp for further instructions.
Yes, serial numbers 5980075 and 5980077 are affected.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2337-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2337-2018 from Terumo. 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.
