Thoratec HeartMate 3 Coring Tool Recalled for Foreign Particle Contamination
Thoratec Corp. is recalling HeartMate 3 Coring Tools because a small black plastic particle was observed in a patient's left ventricle during an implant procedure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a foreign particle contamination risk during a surgical procedure. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where specific injury has not yet been reported in the source text, and it does not meet the criteria for Severe (Score 4) which requires hospitalization reports or significant injury reports.
Plain-English summary
Thoratec Corp. is recalling the Thoratec HeartMate 3 Coring Tool, an optional accessory used with the HeartMate 3 Left Ventricular Assist System (LVAS). The recall involves 650 units distributed nationwide in the United States and in various foreign countries. The Coring Tool is intended to resect a plug of myocardium from the left ventricle to allow for the insertion of the HeartMate 3 inflow cannula.
The recall was initiated after a small black plastic particle was observed in the left ventricle during an implant procedure. The source text does not specify the number of affected patients or report any specific injuries or illnesses resulting from the contamination.
Healthcare providers and patients who have used or are scheduled to use the affected Coring Tools should contact Thoratec Corp. for further instructions. The recall covers specific lot numbers listed in the official FDA record Z-1203-2019.
The recalled product
- Product
- Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The…
- Manufacturer
- Thoratec Corp.
- Affected units
- 650
Distribution
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