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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation

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  Class 2 Device Recall Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation see related information
Date Initiated by Firm September 29, 2021
Create Date November 05, 2021
Recall Status1 Open3, Classified
Recall Number Z-0210-2022
Recall Event ID 88817
Product Classification System, ablation, microwave and accessories - Product Code NEY
Product Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Code Information Lot 516840
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Bryan Dannettell
303-530-6227
Manufacturer Reason
for Recall		 The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
FDA Determined
Cause 2		 Process control
Action Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.
Quantity in Commerce 14 units
Distribution No domestic distribution. Foreign distribution to Hong Kong and UK.
Total Product Life Cycle TPLC Device Report
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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