Home / Recalls / Thoratec Switzerland GMBH / Z-2215-2024

Z-2215-2024 Class II Ongoing

Recalled by Thoratec Switzerland GMBH — Zurich

FDA device recall Z-2215-2024 was initiated by Thoratec Switzerland GMBH on May 22, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 3,425.

Recall Details

Product Type: Devices
Report Date: Jul 3, 2024
Initiation Date: May 22, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,425

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

Reason for Recall

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.

Distribution Pattern

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.

Code Information

REF/Serial Number or Range: 201-30300/ L00610-0004-L06786-0002 201-90401/ 19234129-20119751 and L00610-0011-L08005-0001 201-90411/19234128-20190463 and L03849-0004-L08002-0001 201-90421/19474336-19606873 and L04780-0005-L07601-0001 201-90701/ 19415572 and L03774-0007-L08007-0001 L201-90401/ L00694-0006-L06579-0004 and L201-90401 L201-90411/ 19258710-19605455 and L01627-0007-L07980-0001 L201-90421/ L01716-0010-L06482-0005 UDI-DI: 07640135140689, 07640135140726, 07640135140702, 07640135140719, 07640135140856, 05415067037282, 07640135140894, 07640135149019, 07640135149002, 07640135140702, 07640135140719

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2215-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.