| Class 2 Device Recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology | |
Date Initiated by Firm | August 07, 2017 |
Create Date | February 09, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0558-2018 |
Recall Event ID |
79075 |
510(K)Number | K133821 |
Product Classification |
System, ablation, microwave and accessories - Product Code NEY
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Product | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1 |
Code Information |
UDI 10884521189546, Lot codes: S5LG003PX,S5MG016PX,S5MG018PX,S6AG004X,S6AG005X,S6AG007X,S6BG004X,S6BG011X,S6BG015PX,S6BG017X,S6CG002X,S6CG008X,S6CG014X,S6CG015X,S6CG016X,S6DG002X,S6DG005X,S6DG007X,S6DG010X,S6EG004X,S6EG006X,S6EG008X,S6FG005X,S6FG008X,S6GG007X,S6GG010X,S6HG001X,S6HG003PX,S6HG008PX,S6HG009PX,S6HG012X,S6JG001X,S6KG003X,S6KG005PRX,S6KG005PX,S6KG009X,S6KG016X,S6LG002X,S6MG003X,S6MG018X,S7AG003X,S7BG012PCX,S7CG004X,S7CG006X,S7CG008PCX,S7CG010PCX,S7CG017X,S7DG002X,S7DG005X,S7EG006X,S7FG010PX |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
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For Additional Information Contact | 203-492-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = NEY
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