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U.S. Department of Health and Human Services

Class 2 Device Recall Achieve Electrical Cable

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  Class 2 Device Recall Achieve Electrical Cable see related information
Date Initiated by Firm September 29, 2015
Date Posted November 02, 2015
Recall Status1 Terminated 3 on March 09, 2016
Recall Number Z-0200-2016
Recall Event ID 72115
510(K)Number K102588  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
Product Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.
Code Information Lot U531
Recalling Firm/
Manufacturer		 Medtronic Inc.
8200 Coral Sea St Ne
Saint Paul MN 55112-4391
For Additional Information Contact
888-843-8301
Manufacturer Reason
for Recall		 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic sales reps began notifying customers on 9/29/2015. Customers were told of the issue and were requested to quarantine and return un-used product. A follow-up Urgent Medical Device Recall letter was hand delivered beginning 10/6/2015. The letter again described the issue, identified affected product and asked that un-used product be returned to Medtronic. A response form was asked to be returned to Medtronic. Customer with questions can contact Medtronic AF Solutions at 888-843-8301
Quantity in Commerce 64 units
Distribution Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = MEDTRONIC ABLATION FRONTIERS, LLC
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