2nd Generation CentriMag Primary Console, REF: 201-90401… recallZ-2215-2024 · Thoratec Switzerland GMBH · initiated May 22, 2024

Why it was recalled

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

FDA root cause category: Process control

What the company is doing

On 5/22/24, correction notice distribution started. Customers were asked to do the following: If the console shuts down without alarms or alerts present, follow Instruction for Use (IFU) for Console and Motor malfunction as described in the Section Emergency / Troubleshooting , and switch to a backup console, which must be prepared as required backup components in the immediate vicinity. As stated in the IFU these backup systems should have a battery charge sufficient for at least one hour of operation, be connected to wall power, and be powered off. Note: When the backup console is put into use, the previously used console can be restarted and set up as a backup console. Per the IFU and current practice, a full console backup system is always required to be available in the immediate vicinity of each patient whenever the system is used. Firm is in the process of implementing an additional in-process test by Q3 of 2024, which will ensure that all systems which will be distributed are confirmed to withstand a surge up to 2.0 kV. Distribute this notice to those who need to be aware within your institution and to any organization where potentially affected devices may have been transferred in the event that devices were transferred elsewhere. Complete and return the acknowledgement form via email to [email protected] Should you have any questions about this communication, please contact firm Customer Service at 1 (800) 456-1477

Recall details

Recall number

Z-2215-2024

Status

Open, Classified

Initiated by the company

May 22, 2024

Posted by the FDA

Jun 27, 2024

Recalling firm

Thoratec Switzerland GMBH

Quantity

3,425

Product code

DSQ

FDA submissions

P170038

Distribution

Worldwide - US Nationwide distribution included in the states of CA, PA, FL, IL, NY, AR, GA, WI, AZ, TN, TX, NC, MT, VA, MA, NJ, NE, WV, ME, OK, CO, OH, KC, WA, IN, CT, MI, OR, ID, MO, SC, KY, LA, NM, NV, VT, IA, MD and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRAN, IRAQ, ISRAEL, ITALY, KENYA, KOREA, KUWAIT, LITHUANIA, MACEDONIA MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM.

Product description

2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• 2nd Gen CentriMag Primary Console 201-90411

  Thoratec Switzerland GmbH · Control, Pump Speed, Cardiopulmonary Bypass
  1 recall459 reports