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U.S. Department of Health and Human Services

Class 3 Device Recall STREAMLINE Bipolar Temporary Myocardial Pacing Lead

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  Class 3 Device Recall STREAMLINE Bipolar Temporary Myocardial Pacing Lead see related information
Date Initiated by Firm February 06, 2009
Date Posted April 14, 2009
Recall Status1 Terminated 3 on May 07, 2011
Recall Number Z-1173-2009
Recall Event ID 51292
510(K)Number K963898  
Product Classification Temporary Pacemaker Electrode - Product Code LDF
Product Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
Code Information Lot # JDG880205F
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
Minneapolis MN 55432-5603
For Additional Information Contact
763-505-2562
Manufacturer Reason
for Recall		 Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have b
FDA Determined
Cause 2		 Process control
Action Consignees were sent on 2/6/09 a Medtronic " Urgent Medical Device Recall Notice" dated February 6, 2009. The letter was sent to Risk Mangers. The letter described the product, problem, and requested the removal and quarantine of the affected, unused product. They asked consignees to sign and return the attached recall certificate regarding the status of affected product remaining at their facility. Their Medtronic Sales Representative will contact them to arrange the return of any affected inventory or customers may follow the instructions provided on the attached certificate.
Quantity in Commerce 612
Distribution Nationwide Distribution -- including states of AK, AZ, CA, CO, CT, ID, IL, IN, KS, MI, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, TN, TX, VA, WA, and WI.
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 = LDF and Original Applicant = MEDTRONIC VASCULAR
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