Recall Z-2200-2016 ยท LDF Electrode, Pacemaker, Temporary
Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtro
| Date | Jun 16, 2016 |
| Status | Terminated |
| Reason | This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter was addressed to Health Care Professional. The letter described the problem and the product involved in the recall. The letter described the "Customer Actions" which advised consignees to identify, quarantine and return affected product to Medtronic. Customers were instructed to complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and e-mail to RS.CFQFCA@medtronic.com. For questions, please con |
| Quantity | 11697 (5523 OUS, 6174 US) |
| Distribution | Worldwide Distribution. US nationwide, Albania, Algeria, Australia, Botswana, Bulgaria, Canada, Colombia, France, Gabon, Germany, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Kazakhstan, Macedonia, Mauritius, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Qatar, Russian F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042190 | MODEL 6416 TEMPORARY PACING LEAD SYSTEM Medtronic Vascular, Sep 7, 2004 |