Boston Scientific recalls AngioJet Ultra Consoles-Thrombectomy System models with serial numbers starting 105650-001D, 105650-001H, 105650-001R, 105650-001Z, 105650-002R, and others. Consoles shipped without required Operator's Manual.
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
Boston Scientific is recalling AngioJet Ultra Consoles-Thrombectomy Systems that were shipped without the required Operator's Manual. This means users may not have the instructions needed to safely operate the device, which is used for removing blood clots from arteries and veins.
The consoles were shipped without the required Operator's Manual. Without this manual, medical professionals may not have the necessary instructions to safely operate the device, which is used for removing blood clots from arteries and veins. This could lead to improper use if the device is not operated correctly.
Medical professionals who own or use the AngioJet Ultra Consoles-Thrombectomy System with the listed serial numbers are affected. Patients using the device are not at risk directly from the missing manual but may need to ensure proper operation.
Check the serial number on the console, which starts with 105650-001D, 105650-001H, 105650-001R, 105650-001Z, 105650-002R, or other listed models. The console may also have a unique identifier code like U2541, U2893, etc.
Look for the serial number on the console, which starts with 105650-001D, 105650-001H, 105650-001R, 105650-001Z, 105650-002R, or other listed models.
The consoles were shipped without the required Operator's Manual, which is necessary for safe operation of the device.
No, the device can be used but you must ensure you have the Operator's Manual for safe operation.
Check the serial number on the console, which starts with 105650-001D, 105650-001H, 105650-001R, 105650-001Z, 105650-002R, or other listed models.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0717-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0717-2020 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.
