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U.S. Department of Health and Human Services

Class 2 Device Recall SynCardia temporary Total Artificial Heart System

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  Class 2 Device Recall SynCardia temporary Total Artificial Heart System see related information
Date Initiated by Firm November 02, 2022
Date Posted January 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1022-2023
Recall Event ID 91330
PMA Number P030011 
Product Classification Artificial heart - Product Code LOZ
Product SynCardia Total Artificial Heart System (70CC): 500101-001

SynCardia Total Artificial Heart System (50CC): 570500-000
Code Information SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Recalling Firm/
Manufacturer		 SynCardia Systems LLC
1992 E Silverlake Rd
Tucson AZ 85713-3865
For Additional Information Contact Elizabeth Oei
520-276-5037
Manufacturer Reason
for Recall		 Due to tears reported tears in the cannula due to wear and tear stress.
FDA Determined
Cause 2		 Device Design
Action On 11/02/2022, the firm send an "Urgent Medical Device Correction" Letter via email alerting customers that there is the potential for hole or tear that may occur in the pneumatic cannulae of the temporary Total Artificial Heart (TAH-t). Customers are instructed to: Prior to a hole/tear occurring, train patients to properly inspect the cannulae for holes/ tears and to recognize the signs of a tear/hole. If a hole/tear occurs, the patient should immediately call the hospital to arrange for repair. For Clinicians Only: While SynCardia has not validated the below instructions, there have been literature articles[i][ii] on this method to repair a cannula tear by removing the damaged cannula segment. The repair requires a backup Companion 2 or Freedom portable driver, a secondary driver driveline connector, zip ties, and high-leverage cable cutters. The repair should be implemented quickly by at least two operators following the instructions below. One operator will prepare and operate the backup driver. A second operator will cut and reconnect the cannula. 1. Inspect cannulae for any sign of a tear, hole, or cut, which can be visually detected or detected by listening for a hissing sound or whooshing of air. 2. Prepare a backup driver with an appropriate secondary connector attached to the affected driver driveline. Power on the selected backup driver and keep it on standby for the next repair steps. 3. Using a high-leverage cable cutter cut the cannula through the coil wire slightly distal to the tear to minimize the loss of cannula length. Insert a secondary connector barb (connected to the powered backup driver) into the cut cannula. Secure the cannula to the new connector with zip ties. 4. Disconnect the other undamaged cannula from the primary driver and reconnect it to the backup driver. 5. Change backup driver from standby to run with the correct settings for the patient. For questions contact Customer Support Manager at 1-866-480-1122. In addition to custome
Quantity in Commerce 1,732 systems
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey 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 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
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