FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling specific lots of 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) has issued a Class II recall for the Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2. The recall is being conducted by the manufacturer, Covidien LLC.
The recall was initiated after the firm received consumer reports that the ceramic trocar tip of the antenna disengaged from the needle shaft after an ablation procedure. This defect can result in the tip remaining inside the patient's body.
The affected product was distributed nationwide, including Puerto Rico, Canada, and China. Specific lot codes involved in this recall include S6MG007PX, S6MG010PX, S6MG016PX, S7AG002PX, S7BG005X, S7BG009X, S7DG004X, and S7FG006X. The UDI for the product is 10884521706606. Healthcare providers and patients should contact the manufacturer or their medical provider for instructions on how to proceed.
The recalled product
- Product
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
- 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 (9)
- UDI 10884521706606
- Lot codes: S6MG007PX
- S6MG010PX
- S6MG016PX
- S7AG002PX
- S7BG005X
- S7BG009X
- S7DG004X
- S7FG006X
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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