Recall record at a glance
| Official record | Z-2215-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Thoratec Switzerland GMBH |
| Report date | Jul 3, 2024 |
| Recall initiation date | May 22, 2024 |
| Quantity | 3,425 |
| Location | Zurich, Switzerland |
Official 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
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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