# FDA recall Z-1099-2026

> **Thoratec LLC** · Class II · device recall initiated 2025-10-10.

## Product

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

## Reason for recall

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.

## 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, 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.

## Key facts

- **Recall number:** Z-1099-2026
- **Recalling firm:** Thoratec LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-10
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2026

## Citation

> AI Analytics. FDA recall Z-1099-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1099-2026. Source: US FDA. Licensed CC0.

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