Recall Z-0560-2018 ยท NEY System, Ablation, Microwave And Accessories
Covidien LLC
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
| Date | Aug 7, 2017 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Distribution | Nationwide including PR, Canada, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133821 | EMPRINT ABLATION SYSTEM Covidien, LLC, Apr 28, 2014 |