Recall of Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling Emprint Percutaneous Antennas 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 Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1. 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 in the patient. The affected product is identified by UDI 10884521189553 and specific lot codes listed in the recall documentation. Distribution was nationwide, including Puerto Rico, Canada, and China.
Healthcare providers and patients should contact the manufacturer or their supplier for instructions on how to proceed. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
- 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 10884521189553
- Lot codes: S5LG004PX
- S6AG001X
- S6BG002X
- S6BG005X
- S6BG016PX
- S6CG003X
- S6CG005X
- S6CG017X
- S6DG004X
- S6EG001X
- S6FG001X
- S6FG006X
- S6FG010X
- S6KG002X
- S6KG006PRX
- S6KG006PX
- S6LG004X
- S6MG002X
- S7CG001PCX
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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