Class II FDA device recall · Z-1099-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Why it was recalled

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A  REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers.  REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 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Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Recall record

Recalling firm: Thoratec LLC
Product type: Devices
Recall number: Z-1099-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Pleasanton, CA
Recall initiated: 2025-10-10

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1099-2026 · Source: openFDA enforcement.