Recall of Emprint Percutaneous Antenna Due to Tip Disengagement Risk
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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' (structural defect/significant injury risk).
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2, manufactured by Covidien LLC. The recall was initiated after the firm received consumer reports indicating that the ceramic trocar tip of the antenna can disengage from the needle shaft after an ablation procedure.
This defect poses a risk that the tip may remain inside the patient's body. The affected products were distributed nationwide, including Puerto Rico, Canada, and China. Specific lot codes and UDI numbers are listed in the structured product information.
Healthcare providers and patients should contact their medical device representative or the manufacturer for instructions on how to proceed. The FDA advises that this device should not be used until further notice.
The recalled product
- Product
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
- 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 (15)
- UDI 10884521706590
- Lot codes: S6MG006PX
- S6MG009PX
- S6MG013PX
- S6MG020PX
- S7AG011X
- S7AG012X
- S7BG008X
- S7CG003X
- S7DG003X
- S7DG009X
- S7FG001X
- S7FG002X
- S7FG005X
- S7FG008X
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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