Abbott recalls specific Amplatzer Steerable Delivery Sheath models due to updated instructions for use. Affected units include batch numbers 7963817 to 8277741. Consumers should check their product details.
Instructions for use were updated.
Abbott is recalling certain Amplatzer Steerable Delivery Sheaths because their instructions for use were updated. This recall does not involve a safety hazard but requires users to follow the new instructions to ensure proper use.
The recall is due to updated instructions for use. This means healthcare providers must follow the latest guidelines to ensure safe and effective medical procedures. The hazard is not a physical risk but a procedural update.
Healthcare professionals who use the Amplatzer Steerable Delivery Sheath for medical procedures may be affected. Patients using these devices are not at risk as the recall is about updated instructions, not a safety issue.
Check the model number on the sheath, which is ASDS-14F-075. Look for batch numbers listed: 7963817, 7976534, 7981029, 7990340, 8008111, 8010056, 8025120, 8102214, 8106240, 8234848, 8274323, or 8277741.
Review the model number and batch numbers to confirm if your Amplatzer Steerable Delivery Sheath is affected.
Abbott is recalling these specific models because their instructions for use were updated. This ensures healthcare providers follow the latest guidelines for safe medical procedures.
No, the recall does not require stopping use. Healthcare providers should follow the updated instructions to ensure safe procedures.
Check the model number and batch numbers to see if your product is affected. If it is, follow the updated instructions for use.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0895-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0895-2022 from Abbott. 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.
