Z-2215-2024Class II

2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300...

Name: Z-2215-2024 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300...
Creator: Thoratec Switzerland GMBH
Published: 2024-05-22
License: https://open.fda.gov/license/

Thoratec Switzerland GmbH / initiated 2024-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Thoratec Switzerland GMBH began a recall of 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... on 2024-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2215-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-22
Posted: 2024-06-27
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
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: manufacturing process
FDA 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 [email protected] Should you have any questions about this communication, please contact firm Customer Service at 1 (800) 456-1477
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2215-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2215-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)