Recall Z-1200-2010
Medtronic Inc. Cardiac Rhythm Disease Managment · initiated February 25, 2010
Product
Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.
Codes / lots: Lot Serial No LEN302300V LEN302301V LEN302302V LEN302303V LEN302304V LEN302315V LEN302363V LEN302364V LEN302601V LEN302602V LEN302614V LEN302615V LEN302616V LEN302617V LEN302618V LEN302619V LEN302620V LEN302625V LEN302626V LEN302627V LAQ062840V LAQ062841V LAQ062842V LAQ062843V LAQ062844V LAQ064586V LAQ064587V LAQ064588V LAQ064589V LAQ065336V LAQ065337V LAQ065345V LAQ065346V LAQ065347V LAQ065348V LAQ065349V LAQ066621V LAQ066622V LAQ066623V LAQ067119V LAQ067283V LAQ067284V LAQ067285V LAQ067286V LAQ067287V LAQ067288V LAQ067289V LAQ067999V LAQ068125V LAQ068127V LAQ068128V LAQ068129V LAQ068131V LAQ068132V LAQ068134V LAQ068850V LAQ068851V LAQ068852V LAQ068853V LAQ069466V LAQ069469V LAQ069623V LAQ070057V LAQ070058V LAQ070059V LAQ070074V LAQ070075V LAQ070076V LAQ070077V LAQ070409V LAQ070410V LAQ070411V LAQ070412V LAQ070416V LAQ070417V LAQ070418V LAQ070425V LAQ070426V LAQ070427V LAQ070432V LAQ070433V LAQ070434V LAQ070437V LAQ070487V LAQ070488V LAQ070489V LAQ070585V LAQ070649V LAQ070650V LAQ070651V LAQ070652V LAQ071132V LAQ071133V LAQ071134V LAQ071135V LAQ071136V LAQ071137V LAQ071138V LAQ071139V LAQ071140V LAQ071141V LAQ071143V LAQ071144V LAQ071146V LAQ071803V LAQ071804V LAQ071805V…
Reason for recall
Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.
FDA-determined cause: Packaging
Action taken
Consignees were sent a Medtronic "Important Medical Device Recall" Letter dated February 2010 on 2/25/10. The letter described the problem and the product. Medtronic recommended to immediately remove the affected leads from inventory. Customers with questions, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-505-4636.
Details
- Recall number
- Z-1200-2010
- Initiated
- February 25, 2010
- Posted by FDA
- March 23, 2010
- Terminated
- January 7, 2012
- Product code
- DTB – Permanent Pacemaker Electrode
- Quantity
- 4,863 (US); 6,328 (OUS)
- Distribution
- All States in continental USA including DC except Alaska. OUS: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Iceland, India, Ireland…
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Managment, Saint Paul, MN