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 SynCardia 50cc TAHt

  • 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 SynCardia 50cc TAHt see related information
Date Initiated by Firm August 01, 2023
Date Posted October 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-0126-2024
Recall Event ID 92930
PMA Number P030011 
Product Classification Artificial heart - Product Code LOZ
Product SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Code Information All Lots/ UDI: 00858000003053
Recalling Firm/
Manufacturer		 SynCardia Systems LLC
1992 E Silverlake Rd
Tucson AZ 85713-3865
For Additional Information Contact Elizabeth OEI
203-807-0965
Manufacturer Reason
for Recall		 Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
FDA Determined
Cause 2		 Other
Action On August 22, 2023, SynCardia issued an Urgent Medical Device Correction Notification to all affected consignees via Email. SynCardia asked consignees to take the following actions: 1. You may continue to use the device while the change undergoes FDA review for safety and effectiveness. 2.Ensure that all medical professionals in your institution are informed of this Urgent Medical Device Correction. 3. Please complete the Customer Acknowledgement Form and return it via email to SynCardia Systems, LLC, within five business days of receipt of this letter. 4.For patients with implanted devices affected by this correction, monitor patients closely and take appropriate actions you believe necessary if any issues arise. 5. Adverse reactions or quality problems experienced with this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download the form from www.fda.gov/medwatch/getforms.htm or call 1-800-322-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Quantity in Commerce 114 units
Distribution US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia
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.
PMA Database PMAs with Product Code = LOZ and Original Applicant = SYNCARDIA SYSTEMS, LLC
-
-