Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk
Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a documented mechanical defect that creates a risk of patient harm during biopsy procedures. Although no injuries have been reported in the source material, needle separation or dislodgement during a clinical procedure represents a significant risk-of-harm scenario that meets the High severity criterion.
Plain-English summary
Hologic, Inc. is recalling the Sertera-14 Biopsy Device because the inner needle can separate from the hub, causing either a longer throw of the inner needle or dislodgement of the needle during use.
Approximately 55,335 units with various lot numbers have been distributed nationwide in the United States. The affected model is identified by UDI 15420045504066 and Model Number Sertera-14.
This defect poses a risk of injury during biopsy procedures. Separation or dislodgement of the inner needle could compromise the safety and effectiveness of the procedure.
Patients and healthcare providers who have used or have in inventory the Sertera-14 biopsy device should contact Hologic, Inc. for guidance on device status and next steps.
The recalled product
- Product
- Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
- Manufacturer
- Hologic, Inc
- Affected units
- 55,335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No- Sertera-14
- UDI- 15420045504066
- Lot Numbers: E23B23RL
- E23B23RM
- E23C07RD
- E23C07RF
- E23C31RC
- E23D12RT
- E23D12RU
- E23D27RW
- E23E03RJ
- E23E12RT
- E23E12RU
- E23E29RL
- E23E30RM
- E23F02RG
- E23F07RL
- E23F07RM
- E23F27R
- E23F29RL
Distribution
Distributed nationwide across the United States.
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