Class 2 Device Recall COVIDIEN Emprint Ablation Catheter with Thermosphere Technology

• Date Initiated by Firm: November 23, 2022
• Date Posted: January 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0955-2023
• Recall Event ID: 91318
• Product Classification: System, ablation, microwave and accessories - Product Code NEY
• Product: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
• Code Information: UDI/DI (GTIN): 10884521825765, Lot Number: 520200
• FEI Number: 3004962788
• Recalling Firm/ Manufacturer: Covidien, LLC; 161 Cheshire Ln N Ste 100; Minneapolis MN 55441-5433
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer Reason for Recall: The product is labeled with the incorrect expiration date.
• FDA Determined Cause: Process control
• Action: On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. Return the form via email to RS.GMBFCAMITG@medtronic.com within 30 days of receipt. Contact us at 1-800-255-6774 to receive a return material authorization (RMA) and coordinate inventory replacement/credit. Return unopened affected units to: Medtronic Attention: [Insert RGA #], 4340 Swinnea Rd, Bldg A Memphis, TN 38118. If you have any questions regarding this communication, please contact your Medtronic Representative or Medtronic Customer Service at 800-962-9888.
• Quantity in Commerce: 21 units
• Distribution: Foreign Distribution: Hong Kong
• 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.