Boston Scientific recalls FARADRIVE Steerable Sheath Clear devices with specific lot numbers due to potential hemostatic valve damage causing air embolism. Affected patients should consult their physician.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Boston Scientific is recalling a specific model of steerable sheath used in heart procedures because improper insertion can damage a valve, leading to air entering the bloodstream. This risk could cause serious harm to patients during medical procedures.
The sheath has a hemostatic valve that can be damaged if the dilator is not inserted straight through the center and fully advanced. This damage may allow air to enter the bloodstream, potentially causing air embolism, which can lead to serious complications during medical procedures.
Patients undergoing heart procedures with the recalled sheath model are most at risk. Healthcare providers using the device for vascular access are also affected.
Check the product label for the model name 'FARADRIVE STEERABLE SHEATH CLEAR' and lot numbers listed in the recall (e.g., CL12697, CL12698, etc.). The device is used for heart procedures and vascular access.
Look for the model name 'FARADRIVE STEERABLE SHEATH CLEAR' and lot numbers from the list provided in the recall.
If you have the recalled device, contact your healthcare provider to discuss potential risks and next steps.
The recalled model is FARADRIVE STEERABLE SHEATH CLEAR with specific lot numbers listed in the recall.
Check the product label for the model name 'FARADRIVE STEERABLE SHEATH CLEAR' and lot numbers from the list provided in the recall (e.g., CL12697, CL12698, etc.).
Contact your healthcare provider to discuss potential risks and next steps. The recall does not include a repair or replacement option.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2755-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2755-2026 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.
