Z-1022-2023Class II

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC)...

Name: Z-1022-2023 SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC)...
Creator: SynCardia Systems LLC
Published: 2022-11-02
License: https://open.fda.gov/license/

SynCardia Systems LLC / initiated 2022-11-02 / Open, Classified / root cause: design

FDA source

SynCardia Systems LLC began a recall of SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000 on 2022-11-02. FDA classified it as Class II and gives the reason as "Due to tears reported tears in the cannula due to wear and tear stress". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1022-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-02
Posted: 2023-01-27
Recalling firm: SynCardia Systems LLC
Product: SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Product code: LOZ Artificial Heart
Reason for recall: Due to tears reported tears in the cannula due to wear and tear stress.
Root cause tag: design
FDA 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 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.
Product codes and lots: SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1022-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1022-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27

Product code LOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)