Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit

  • 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 2 Device Recall Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit see related information
Date Initiated by Firm January 14, 2020
Date Posted February 14, 2020
Recall Status1 Open3, Classified
Recall Number Z-1450-2020
Recall Event ID 84837
Product Classification Sizer, heart-valve, prosthesis - Product Code DTI
Product Medtronic
Simulus 850
Semi Rigid Ring/Band Accessory Kit
Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Code Information GTIN: 00643169707573
Recalling Firm/
Manufacturer		 Medtronic CoreValve LLC
1851 E Deere Ave
Santa Ana CA 92705-5720
For Additional Information Contact Rick Leonard
763-514-9609
Manufacturer Reason
for Recall		 Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm initiated the recall by email or verbal contact on 01/14/2020. The direct consignees (sales representatives) were directed to quarantine and return the affected product. On 02/05/2020, consignees (hospitals) were notified by letter delivered by the Medtronic Sales Representatives. The notices directed the consignee to not use the affected product for clinical use, quarantine and return affected product. Affected product will be replaced by Medtronic.
Quantity in Commerce 6
Distribution US Nationwide distribution in the states of Ohio and Kansas.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-