HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction
HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
HeartWare Inc is recalling the HeartWare Ventricular Assist System (HVAD) due to complaints regarding the retraction of pins within the driveline connector. The affected catalog numbers are 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. This device is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
The recall covers 3,747 units currently in use. The distribution is worldwide, including the United States and numerous international countries. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Patients and healthcare providers should contact HeartWare Inc for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
- Manufacturer
- HeartWare Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,747
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial #: ALL HeartWare HVAD systems currently in use.
Distribution
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