Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip due to difficulty tracking over guidewires, which may cause procedural delays. Affected units include specific lot numbers and model codes.
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Boston Scientific is recalling Sensor Nitinol Wire with Hydrophilic Tip because it has caused difficulty or inability to track the device over guidewires during procedures. This may lead to procedural delays requiring device exchange.
The wire's hydrophilic tip can cause difficulty or inability to track over guidewires during medical procedures. This may lead to procedural delays as the device needs to be exchanged.
Medical professionals using this device during procedures are likely affected. Patients undergoing procedures with this specific wire model may be at risk of procedural delays.
Check for the model code UPN: M0066703051 (box of 5) or UPN: M0066703050 (single unit). Affected units have specific lot numbers listed in the recall notice.
Identify the model code on the device packaging or label, which may be UPN: M0066703051 or UPN: M0066703050.
Boston Scientific recalls this wire due to an increase in complaints about difficulty or inability to track the device over guidewires, which may cause procedural delays requiring device exchange.
Check the model code and lot numbers listed in the recall notice to determine if your device is affected. If it is, contact Boston Scientific for further instructions.
The recall describes procedural delays due to tracking issues, not direct injury risks. The hazard level is low risk as it does not involve immediate danger to users.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1729-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1729-2020 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.
