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, posing a significant risk of injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1. The recall is due to reports that the ceramic trocar tip of the antenna may disengage from the needle shaft after an ablation procedure.
This defect can result in the tip remaining inside the patient. The affected products were distributed nationwide, including in Puerto Rico, Canada, and China.
Healthcare providers and patients should contact the manufacturer for further instructions on how to proceed. The specific lot numbers and UDI codes for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
- 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 10884521189539
- Lots S5LG002PX
- S5MG004PX
- S5MG009PX
- S5MG010PX
- S5MG013PX
- S5MG017PX
- S5MG019PX
- S6AG002X
- S6AG003X
- S6AG006X
- S6AG009X
- S6AG010X
- S6BG001X
- S6BG006X
- S6BG012X
- S6BG013X
- S6BG014PX
- S6CG001X
- S6CG004X
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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