• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic EnVeo R Loading System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Medtronic EnVeo R Loading System see related information
Date Initiated by Firm July 15, 2015
Date Posting Updated August 05, 2015
Recall Status1 Terminated 3 on May 20, 2016
Recall Number Z-2264-2015
Recall Event ID 71719
PMA Number P130021 
Product Classification Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
Product EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C.

Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Code Information 0007254814, 0007266413, 0007332504, 0007332506, 0007332508, 0007332510, 0007343321, 0007343324, 0007343327, 0007350825, 0007350837, 0007354113, 0007354245, 0007366949, 0007369883, 0007393098, 0007393101, 0007408862, 0007408865, 0007408867, 0007408869, 0007428258, 0007428260, 0007428263, 0007435169, 0007439358, 0007439360, 0007439362, 0007456292, 0007456298, 0007462901, 0007462903, 0007462905, 0007476215, 0007476217, 0007476219, 0007482219, 0007482222, 0007482226, 0007486826, 0007492356, 0007495691, 0007495694, 0007495696, 0007508883, 0007508885, 0007508891, 0007515698, 0007515700, 0007515703, 0007522595, 0007522598, 0007522600, 0007522603, 0007530963, 0007530973, 0007537892, 0007537894, 0007569474, 0007569477, 0007569482, 0007573778, 0007573785, 0007573788, 0007573791, 0007579940, 0007579944, 0007579948, 0007579951, 0007592664, 0007592666, 0007592669, 0007592672, 0007598984.
Recalling Firm/
Manufacturer
Medtronic Cardiovascular Surgery-the Heart Valve Division
1851 E Deere Ave
Santa Ana CA 92705-5720
For Additional Information Contact Lauralie Millikan
763-514-9605
Manufacturer Reason
for Recall
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
FDA Determined
Cause 2
Process control
Action An Urgent Medical Device Recall Letter dated July 2015 will be be sent to customers who purchased the EnVeo R Loading System because Medtronic has received 8 reports related to this issue out of 7347 potentially affected units. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.
Quantity in Commerce 6,912 units total (540 units in US)
Distribution Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NPT and Original Applicant = MEDTRONIC COREVALVE LLC
-
-