Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect where a component may remain in the patient, which aligns with the rubric criteria for significant injury or structural defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1. The recall was initiated after the firm received consumer reports that the ceramic trocar tip of the antenna disengaged from the needle shaft following an ablation procedure.
This defect can result in the tip remaining inside the patient. The product was distributed nationwide, including Puerto Rico, Canada, and China. The recall includes specific lot codes and UDI 10884521189546.
Healthcare providers and consumers should stop using the affected devices and contact the recalling firm, Covidien LLC, for further instructions on how to proceed.
The recalled product
- Product
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
- Manufacturer
- Covidien LLC
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)
- UDI 10884521189546
- Lot codes: S5LG003PX
- S5MG016PX
- S5MG018PX
- S6AG004X
- S6AG005X
- S6AG007X
- S6BG004X
- S6BG011X
- S6BG015PX
- S6BG017X
- S6CG002X
- S6CG008X
- S6CG014X
- S6CG015X
- S6CG016X
- S6DG002X
- S6DG005X
- S6DG007X
- S6DG010X
Distribution
Part of a larger recall action
This product is one of 6 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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