Boston Scientific recalls Innova Self-Expanding Stent Systems (180mm) with material numbers H74939180051870 to H74939293081870 due to possible failure to fully release from delivery system.
Stent possibly unable to be fully released from the delivery system.
Boston Scientific is recalling specific models of Innova Self-Expanding Stent Systems (180mm) because they may not fully release from the delivery system. This could lead to improper placement during medical procedures.
The stent may not fully release from the delivery system during medical procedures, potentially causing improper placement in the blood vessels. This could lead to complications like blockages or inadequate treatment.
Medical professionals who use these stent systems for vascular procedures are most at risk. Patients who received these stents during procedures are not affected by this recall.
Check for material numbers starting with H74939180051870 through H74939293081870 on the product packaging. The stent systems are labeled for use in the superficial femoral artery and proximal popliteal artery.
Look for material numbers on the packaging that start with H74939180051870 through H74939293081870.
The stent may not fully release from the delivery system during medical procedures, potentially causing improper placement.
No, patients who received this stent during procedures are not affected by this recall.
Medical professionals should check the product label for the material numbers and contact Boston Scientific if they have the recalled stent.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0686-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0686-2018 from Boston Scientific. 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.