Drug recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
FDA recall event 79075 · Class II · Covidien LLC
Key facts
| Event ID | 79075 |
|---|---|
| Recall numbers | Z-0556-2018, Z-0557-2018, Z-0558-2018, Z-0559-2018, Z-0560-2018, Z-0561-2018 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1, Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2, Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1, Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2, Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 7, 2017 |
| Report date | Feb 14, 2018 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: