—#79635

Product

Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432

FDA product code: LDF — Electrode, Pacemaker, Temporary
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K963898
Affected lot / code info: Lot # JDG880205F

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-02-06
Posted by FDA: 2009-04-14
Terminated: 2011-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79635. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.