Heartware HVAD Pump Outflow Graft Recalled for Potential Tears and Screw Breakage
Heartware, Inc. is recalling HVAD Pump Outflow Grafts because the graft may tear or the strain relief screw may break during pre-implant assembly.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical) regardless of other factors.
Plain-English summary
Heartware, Inc. is recalling the Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125. The recall involves 20,147 devices that were distributed worldwide. All lots and serial numbers in distribution are affected.
The recall is being issued because the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. This defect poses a risk of device failure during the surgical preparation process.
Healthcare providers and patients should contact Heartware, Inc. for instructions on how to proceed with the recall. 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.
The recalled product
- Product
- Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
- Manufacturer
- Heartware, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 20,147
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)
- All lots and serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Heartware, Inc.
See all →- HighHVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateHeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateVentricular Assist Device Instructions Updated for Alarm and Useful Life Clarification
FDA (Devices) · 2023-12-13
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12