Covidien Emprint Short Percutaneous Antenna with Thermosphere… — Class II medical device recall Z-0626-2019
Ongoing recall by Covidien LLC, reported 2018-12-26, distributed nationwide. The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from
| Recall number | Z-0626-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2018-11-15 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10884521706583 |
| Lot numbers | S7HG002X, S7HG003X, S7HG005KX, S7HG006KX, S7HG022LX, S7HG023LX, S7HG024LX, S7HG025LX, S7HG029LX, S7HG040X, S7HG041X, S7HG045X, S7HG049X, S7JG007X, S7JG011X, S7JG033LX, S7JG034X, S7JG035X, S7JG041LX, S7JG042LX, S7JG043LX, S7JG044LX, S7JG045LX, S7JG046LX, S7JG047LX, S7KG023LX, S7KG029X, S7KG033X, S7KG039X, S7KG040X, S7KG042X, S7LG001X, S7LG002X, S7LG006X, S7LG011X, S7LG012X, S7MG008LX, S7MG009LX, S7MG011X, S7MG012X and 30 more |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0626-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.