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Use caution Medical device recall · FDA · Published October 10, 2025

Thoratec CentriMag Blood Pump Recall: Pump May Not Securely Lock Into Motor

Thoratec recalls CentriMag Blood Pumps (REFs 102953, 201-20003, 201-90010, 201-90016) and CentriMag RVAD HDE KIT (REF 104318) due to risk of pump not securely locking into motor, which could cause particulate, heat, or serious complications.

🇺🇸 FDA recall #Z-1099-2026Medical deviceThoratec ›
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Recalling firmThoratec LLC6035 Stoneridge Dr · Pleasanton, CA 94588-3270
✎ GovInfoNow plain-language explainer

What happened, in plain English

Thoratec is recalling certain CentriMag Blood Pumps and CentriMag RVAD HDE Kits because they may not lock securely into the motor. This could lead to pump alarms, increased heat, or serious complications like stroke or death. Affected units have specific reference numbers listed in the recall. Read more at govinfonow.com/recall/51072-thoratec-centrimag-blood-pump-recall-pump-may-not-securely-lock.

Source Summary by GovInfoNow · govinfonow.com/recall/51072-thoratec-centrimag-blood-pump-recall-pump-may-not-securely-lock · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1099-2026

Cite this page

“Thoratec CentriMag Blood Pump Recall: Pump May Not Securely Lock Into Motor.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51072-thoratec-centrimag-blood-pump-recall-pump-may-not-securely-lock. Based on FDA recall #Z-1099-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2026%22&limit=1).

Why it’s dangerous

The pump may not fit properly into the motor or fail to lock securely using the screw-in feature. This can cause pump alarms, increased heat, particulate release, and potentially lead to stroke, embolism, or death in patients requiring ECMO support.

Who’s affected

Patients using CentriMag Blood Pumps or CentriMag RVAD HDE Kits for ECMO support are most at risk. Healthcare providers and patients with these devices should check if their units are affected.

How to tell if you have this one

Check for reference numbers: CentriMag Blood Pump (REFs 102953, 201-20003, 201-90010, 201-90016), CentriMag RVAD HDE KIT (REF 104318), or CentriMag Pre-connected Pack (REF CMAEK00).

  • Brand
    Thoratec
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Reference

    Look for reference numbers on the pump or kit: 102953, 201-20003, 201-90010, 201-90016 for Blood Pumps; 104318 for RVAD HDE Kits.

  2. Contact Thoratec

    If your unit has an affected reference number, contact Thoratec for instructions on how to fix or replace the pump.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Oct 10, 202512. FDA classified it Class II: Jan 15, 202623. Published in FDA’s Enforcement Report: Jan 21, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1099-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1099-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA