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Recall Observatory FDA recall evidence

Device product

Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

Z-0103-2019

September 05, 2018

Class II

Product summary

Firm
Thoratec Switzerland GMBH
Event
Event 80917
Status
Terminated
Classification
Class II
Quantity
1569
Official record key
device-enforcement:Z-0103-2019

Official wording

Reason: Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

Code information: UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.

Distribution pattern: U.S.: OR, AZ, CA, ID, WA, WI, NY, MA, CT, NJ, ME, RI, IL, MI, TN, OH, IN, KY, IA, AL, FL, NC, GA, SC, VA, MD, DC, PA, WV, DE, MN, MT, NE, CO, NM, UT, AR, MO, MC, TX, OK, LA, MS, ND

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

Field note

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