FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling specific lots of the Covidien Emprint Short Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft during use, 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 significant injury/property-damage reports or structural defects).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2. This medical device is intended for percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including the ablation of nonresectable liver tumors. The recall covers specific lot numbers distributed nationwide in the United States.
The recall was initiated after the manufacturer, Covidien LLC, received consumer reports that the ceramic trocar tip of the antenna could disengage from the needle shaft after an ablation procedure. If this occurs, the tip may remain inside the patient. The FDA classifies 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, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities that have used or possess these specific lots of the Emprint Short Percutaneous Antenna should stop using the product immediately. They should contact the recalling firm, Covidien LLC, for instructions on how to return the affected units. Patients who have undergone procedures using these specific devices should consult their healthcare provider if they have concerns about the integrity of the procedure or potential retained foreign objects.
The recalled product
- Product
- Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
- Manufacturer
- Covidien LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · foreign object retention
See all →- SevereStryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture
FDA (Devices) · 2020-10-28
- HighEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01
- HighMedline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
FDA (Devices) · 2019-08-14
- SevereFDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement
FDA (Devices) · 2018-12-26
- SevereFDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA (Devices) · 2018-12-26