FDA Medical Device Recalls (openFDA)
Thoratec Switzerland GMBH: 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
- Recall number
- Z-2215-2024
- Recalling firm
- Thoratec Switzerland GMBH
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2024-05-22
- Posted
- 2024-06-27
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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 CentriMagNotices@abbott.com Should you have any questions about this communication, please contact firm Customer Service at 1 (800) 456-1477
- Quantity
- 3,425
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P170038"]
- Product code
- DSQ
- Firm FEI
- 3003306248
- Firm city
- Zurich
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28