Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 8, 2020
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes S
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Thoratec Corp. recalled HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI o… - a moderate-severity action.
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI o… was recalled by Thoratec Corp. in January 8, 2020. Reason: Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power un…. Check the official notice for the remedy. Verify recall #Z-0746-2020 with the FDA Devices before acting.
The recall
Thoratec Corp. issued this moderate-severity FDA Devices recall-Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power un….
- Moderate
- severity level
- 14K units
- affected scope
- Class II
- classification
- January 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0746-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0746-2020) was formally reported on January 8, 2020, with the manufacturer initiating the action on December 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Thoratec Corp. is listed as the recalling firm, operating out of Pleasanton, CA. Federal records list the affected scope as 13871.
The documented reason for this recall is: Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13871
Related Recalls
6
3 from same agency
Product description
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.
Reason for recall
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0746-2020 |
| Date reported | January 8, 2020 |
| Date initiated | December 2, 2019 |
| Recalling firm | Thoratec Corp. |
| Firm location | Pleasanton, CA |
| Affected scope | 13871 |
| Distribution | US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0746-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.. Recalled by Thoratec Corp.. Units affected: 13871.
Why was this product recalled? ▼
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2020. Severity: Moderate. Recall number: Z-0746-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0746-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 8, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.