Thoratec Switzerland GMBH Recall 94588
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
Thoratec Switzerland GMBH Recall 94588 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2215-2024 |
| Event ID | 94588 |
| Event 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 |
| Product Type | Devices |
| 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. |
| Quantity | 3,425 |
| Recall Reason | 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. |
| Device Classification | 20240703 |
| Device Code Info | 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 |
| Center Classification Date | 20240627 |
| Recall Initiation Date | 20240522 |
| Recalling Firm | Thoratec Switzerland GMBH |
| Initial Notification | Letter |
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