Terminated

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.

FDA Recall Z-1200-2010 · Posted 2010-03-23

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Managment

Recall StatusTerminated

Product CodeDTB

Date Initiated2010-02-25

Date Terminated2012-01-07

Product Quantity4,863 (US); 6,328 (OUS)

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.

Firm Action

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.

Root Cause

Packaging

Distribution Pattern

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, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vatican City, Venezuela, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902002MODELS 5069/5071 MYOCARDIAL PACING LEADSMedtronic Vascular · 1990-09-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.