Recall Z-1173-2009 ยท LDF Electrode, Pacemaker, Temporary
Medtronic Inc
Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
| Date | Apr 14, 2009 (initiated Feb 6, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963898 | MODEL 6495 BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular, Jul 22, 1997 |