• 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 Posted August 05, 2015
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NPT and Original Applicant = MEDTRONIC COREVALVE LLC
-
-