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Open, Classified

Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

FDA Recall Z-2035-2023 · Posted 2023-06-29

Recalling FirmHologic, Inc
Recall StatusOpen, Classified
Product CodeKNW
Date Initiated2023-05-02
Product Quantity756 units

Reason for Recall

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

Firm Action

Hologic issued Urgent Medical Device Correction letter on 5/2/23. Letter states reason for recall, health risk and action to take: " Please properly dispose of any product(s) from this lot you currently have in your inventory. You will be issued a credit on your account for the affected product(s). If you wish to reorder product, please place a new order via your preferred procurement method. " Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. o www.novasyte.com/hologic/sertera-2023 " Hologic has partnered with IQVIA to conduct follow-up communications should no response be received to this letter. . If you have any questions, please do not hesitate to reach out to Technical Support at [email protected]

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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