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SynCardia Total Artificial Heart System (70CC): 500101-001 recallZ-1022-2023 · SynCardia Systems LLC · initiated Nov 2, 2022

Class II Open, Classified All recalls posted in January 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from SynCardia Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to tears reported tears in the cannula due to wear and tear stress.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-1022-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Nov 2, 2022
Posted by the FDA
Jan 27, 2023
Recalling firm
SynCardia Systems LLC
Quantity
1,732 systems
Product code
LOZ
FDA submissions
P030011
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 description

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Code information (models, lots, serial numbers)

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Other devices under the same FDA submission

9 devices cleared under P030011 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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