Sertera 14 Gauge Biopsy Device: Needle Detachment Risk
Hologic's Sertera 14 Gauge Biopsy Device may experience inner needle detachment or discharge during use, which could delay breast biopsy surgery. The company is recalling 756 units nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm medical device where the inner needle may detach or discharge, potentially causing surgical complications or delays during patient procedures. Although FDA Class II and no illnesses have been reported, the device malfunction hazard in a surgical context meets the rubric criterion for High severity.
Plain-English summary
Hologic, Inc. is recalling the Sertera 14 Gauge Biopsy Device (Lot E22H19RM, UDI-DI: 15420045504066). This device is designed to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. The company identified that the inner needle may detach or discharge during use, potentially interrupting or delaying the biopsy procedure.
The recall affects 756 units distributed nationwide in the United States. Healthcare providers and surgical centers with this lot number should immediately cease use and contact Hologic for replacement or return instructions.
Patients and healthcare providers with concerns about this device should report any adverse events to the FDA MedWatch program. No illnesses or injuries related to this malfunction have been reported.
The recalled product
- Product
- Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
- Manufacturer
- Hologic, Inc
- Affected units
- 756
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 (1)
- UDI-DI: 15420045504066 Lot Number: E22H19RM
Distribution
Distributed nationwide across the United States.
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