Recall Z-1022-2023 ยท LOZ Artificial Heart
SynCardia Systems LLC
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
| Date | Jan 27, 2023 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| Reason | Due to tears reported tears in the cannula due to wear and tear stress. |
| Root cause | 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 l |
| Quantity | 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, Le |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.