Arrow recalls OnControl Bone Lesion Biopsy System Tray (Product Code 9464-VC-006) due to difficulty inserting biopsy ejector rod, risking repeat procedures. Affected units sold in US/EU with specific lot numbers.
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
Arrow recalls bone biopsy trays that may prevent proper sample collection, requiring repeat procedures. This could lead to longer surgery times and increased patient risk.
The biopsy ejector rod may not insert properly into the cannula, causing the biopsy sample to be collected incorrectly. This often requires repeating the procedure, which increases surgery time and patient risk.
Medical professionals using the OnControl Bone Lesion Biopsy System for vertebral body or bone lesion biopsies. Patients undergoing these procedures are at risk of longer surgeries.
Check for Product Code 9464-VC-006 (US) or 9464-EU-001 (EU) with specific lot numbers listed in the recall notice. The device is used for bone biopsies of the vertebral body and bone lesions.
Identify the product code on the device label: 9464-VC-006 for US units or 9464-EU-001 for EU units.
Reach out to Arrow International for specific guidance on whether your unit requires action.
The biopsy ejector rod may not insert properly into the cannula, preventing correct sample collection and requiring repeat procedures.
Check the product code and lot numbers listed in the recall notice. Contact Arrow International for specific guidance.
The recall is due to potential need for repeat procedures, which could increase surgery time and patient risk, but does not directly cause injury.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1374-2021 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1374-2021 from Arrow. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
