Device brand name · Biventricular replacement device
Syncardia 70cc Temporary Total Artificial Heart Tah-T: medical device reports filed with FDA
204 reports name it, 2016–2023. Manufacturer given most often on reports: Syncardia Systems. Product code LOZ.
- 204
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 16.7%
- classified as malfunction
- 81.1% across the product code
- 58.8%
- classified as death, as reported
- 120 reports · not verified by FDA
FDA's MAUDE database holds 204 reports that name the brand "Syncardia 70cc Temporary Total Artificial Heart Tah-T" (biventricular replacement device), received between January 2016 and May 2023; the manufacturer given most often on reports is Syncardia Systems. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are death (58.8%), injury (24.5%) and malfunction (16.7%); across all artificial heart reports (product code LOZ) death is recorded in 10.4% and malfunction in 81.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material puncture/hole (7.4%), mechanical problem (4.4%) and material integrity problem (1.5%). The patient problems coded most often are death, multiple organ dysfunction syndrome and hemorrhage/blood loss/bleeding. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,727 reports carrying product code LOZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material puncture/hole | 15 | 7.4% | 0.7% |
| Mechanical problema mechanical problem | 9 | 4.4% | 5.6% |
| Material integrity problema problem with the device material | 3 | 1.5% | 1.2% |
| Material discolored | 2 | 1% | 0.3% |
| Material too rigid or stiff | 2 | 1% | 0.2% |
| Physical property issue | 2 | 1% | 1% |
| Connection problema connection problem | 1 | 0.5% | 1.2% |
| Contamination /decontamination problem | 1 | 0.5% | 0.1% |
| Crackthe device cracked | 1 | 0.5% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 10.2% |
| Device operational issue | 1 | 0.5% | 1.1% |
| Disconnection | 1 | 0.5% | 0.5% |
| Human factors issue | 1 | 0.5% | 0.1% |
| Insufficient device problem information | 1 | 0.5% | 0.6% |
| Output problem | 1 | 0.5% | 3.1% |
| Restricted flow rate | 1 | 0.5% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 42 | 20.6% |
| Multiple organ dysfunction syndromeseveral organs failing | 36 | 17.6% |
| Hemorrhage/blood loss/bleeding | 35 | 17.2% |
| Bacterial infectiona bacterial infection | 26 | 12.7% |
| Sepsisa severe body-wide response to infection | 21 | 10.3% |
| Respiratory failurethe lungs could not supply enough oxygen | 20 | 9.8% |
| Stroke/cva | 16 | 7.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 7.4% |
| Renal failurekidney failure | 14 | 6.9% |
| Renal impairmentreduced kidney function | 14 | 6.9% |
| Hemolysis | 12 | 5.9% |
| Neurological deficit/dysfunction | 11 | 5.4% |
| Thrombosis/thrombus | 7 | 3.4% |
| Hemorrhage, cerebral | 4 | 2% |
| Convulsion/seizure | 3 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Syncardia 70cc Temporary Total Artificial Heart Tah-T | Product code LOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 204 | 3,727 | 26,136,888 |
| Share of that pool | — | 5.5% | 0% |
| Classified as death, per 1,000 reports | 588 | 104 | 9 |
| Classified as injury | 24.5% | 8.1% | 36.2% |
| Classified as malfunction | 16.7% | 81.1% | 62.3% |
| Filed by the manufacturer | 100% | 98.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Syncardia Freedom Driver | 1,201 | 26 | 0.9% |
| Syncardia Companion 2 Driver | 848 | 5 | 0.4% |
| Syncardia 70cc Tah-T | 324 | 0 | 54% |
| Syncardia Freedom Onboard Battery | 191 | 3 | 0% |
| Syncardia Circulatory Support System Console | 276 | 0 | 0.4% |
| Heartmate | 219 | 12 | 3.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Syncardia 70cc Temporary Total Artificial Heart Tah-T reports
How many FDA reports name Syncardia 70cc Temporary Total Artificial Heart Tah-T?
204 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
death (58.8%), injury (24.5%) and malfunction (16.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material puncture/hole (7.4%), mechanical problem (4.4%), material integrity problem (1.5%), material discolored (1%) and material too rigid or stiff (1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Syncardia 70cc Temporary Total Artificial Heart Tah-T was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.