Overview
A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.
This specific medical device recall involving Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A is classified as Class II, and was reported on June 24, 2026 by Thoratec LLC.
The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.
What Happened
Thoratec LLC initiated action on Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A on June 24, 2026 after identifying a device performance or malfunction concern. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.
The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.
Affected Products
The product identified in this notice is Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A, manufactured or distributed by Thoratec LLC.
FDA records describe the affected product as: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power…
Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.; a reported quantity of 694; distribution reported as Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA,…; origin or reporting location of Pleasanton, CA, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.
Reason
Based on FDA records, this notice was driven by a device performance or malfunction concern. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.
According to the FDA's Device Enforcement Report database, the stated reason was: "Due to 11 volt Backup Battery failures."
The underlying cause of an issue like this can range from a manufacturing deviation at a single facility to a broader design or formulation problem. The official FDA record linked at the end of this article is the authoritative source for the full technical explanation.
Health Risks
This notice is classified Class II. A Class II classification means the product may cause temporary or medically reversible health consequences, and the probability of serious adverse health consequences is considered remote. Most people affected by a Class II issue do not experience lasting harm, but temporary symptoms are possible.
The specific health risk depends heavily on the nature of the underlying issue with Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A — for example, a contamination concern carries a different risk profile than a labeling error, and a device malfunction carries a different risk profile than a potency issue. Read the "Reason" section above together with this section rather than in isolation.
Recommended Actions
If you use Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A and rely on it for an ongoing health need, do not stop using the device on your own without a plan — talk to the prescribing clinician or device supplier first about whether a replacement or alternative is needed.
Check the lot numbers, NDC codes, or serial numbers on your product against the identifiers listed in the official FDA record (linked at the end of this article), since recalls often apply to specific batches rather than an entire product line.
Follow the specific instructions in the official notice regarding whether to return the product to the pharmacy or manufacturer, dispose of it, or simply stop use and await further guidance. Report any adverse effects you experienced while using this product to the FDA's MedWatch program (fda.gov/medwatch or 1-800-FDA-1088).
Who Should Be Concerned
This notice is most directly relevant to patients and caregivers who currently have Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A in their possession, pharmacies and distributors who stock it, and clinicians who prescribe or use it. If none of those describe you, this notice has limited practical relevance beyond general awareness.
If you are unsure whether this notice applies to you, the safest approach is to check your own product packaging or prescription against the identifying details in the official FDA record, or simply ask your pharmacist directly.
Important Dates
This notice was reported to the FDA on June 24, 2026. That date reflects when the record was published or reported, which may be after the underlying issue was first identified internally by the manufacturer.
For reference, FDA records associate this notice with recall number Z-2519-2026 and event ID 99023. You can use this identifier to search for the most current status directly on FDA.gov.
Recall status, label language, and safety communications can all be updated after initial publication as the FDA and the responsible firm gather more information. Treat any specific date in this article as accurate as of when this article was generated, and confirm current status against the official source before making decisions.
Key Takeaways
- ●This is a medical device recall involving Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A, reported in connection with Thoratec LLC.
- ●FDA records classify this notice as Class II.
- ●The underlying reason relates to a device performance or malfunction concern.
- ●Do not stop a prescribed medication or a relied-upon device without first consulting your healthcare provider.
- ●Always confirm the current, complete details against the official FDA source linked at the end of this article.
- ●If you experience a health effect you believe is related to this product, you can report it to the FDA's MedWatch program.
Official FDA Source
This article summarizes and explains medical device recall information published directly by the FDA. Always refer to the official source for the complete, authoritative record.
FDA Medical Device RecallsFrequently Asked Questions
What is this medical device recall about?
This medical device recall concerns Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A, associated with Thoratec LLC. It was reported based on a device performance or malfunction concern. See the "What Happened" and "Reason" sections above for a full plain-language explanation.
Is every unit of Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A affected?
Not necessarily. Recalls and device actions typically apply to specific lots, batches, or serial number ranges rather than every unit ever distributed. Check the identifying details in the official FDA record against your specific product before assuming it is affected.
Should I stop using Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A immediately?
Do not make that decision without guidance. For a prescription medication, abruptly stopping treatment can carry its own risks — talk to your prescriber or pharmacist first. For a device, ask the supplier or clinician about a safe replacement plan before discontinuing use on your own.
What recall classification applies here, and what does it mean?
This notice is classified Class II. Class I is the most serious (reasonable probability of serious harm or death), Class II involves a remote probability of serious harm with possible temporary effects, and Class III is unlikely to cause any adverse health consequence but violates FDA regulations.
References
Medicines Mentioned in This Article
Medical Disclaimer: This article is provided for educational purposes only and does not constitute medical advice, diagnosis, or treatment. It is an independent summary generated from official FDA data and is not a substitute for professional medical guidance. Always consult a licensed healthcare provider or pharmacist before starting, stopping, or changing any medication or medical device, and before making any decision based on the information presented here. This content is sourced from official FDA communications and public data; for the complete and authoritative record, refer to the official FDA source linked on this page.