Emprint recallZ-0557-2018 · Covidien LLC · initiated Aug 7, 2017
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
FDA root cause category: Device Design
What the company is doing
All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.
Recall details
- Recall number
- Z-0557-2018
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2017
- Recalling firm
- Covidien LLC
- Product code
- NEY
- FDA submissions
- K133821
- Distribution
- Nationwide including PR, Canada, China
Product description
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
Code information (models, lots, serial numbers)
UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Emprint CA15L2Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES2 recalls1 death41 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79075).
- Z-0556-2018 · Open, ClassifiedCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
- Z-0558-2018 · Open, ClassifiedCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
- Z-0559-2018 · Open, ClassifiedCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
- Z-0560-2018 · Open, ClassifiedCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
- Z-0561-2018 · Open, ClassifiedCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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