Device brand name · Biventricular replacement device
Syncardia 70cc Tah-T: medical device reports filed with FDA
324 reports name it, 2016–2024. Manufacturer given most often on reports: Syncardia Systems. Product code LOZ.
- 324
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 7.4%
- classified as malfunction
- 81.1% across the product code
- 54%
- classified as death, as reported
- 175 reports · not verified by FDA
324 medical device reports received by FDA name the brand "Syncardia 70cc Tah-T" (biventricular replacement device); the manufacturer given most often on reports is Syncardia Systems; received from February 2016 to October 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 2 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 (54%), injury (38.6%) and malfunction (7.4%); 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 device operational issue (3.1%), physical property issue (2.5%) and connection problem (1.9%). The patient problems coded most often are death, bacterial infection and respiratory failure. 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 |
|---|---|---|---|
| Device operational issue | 10 | 3.1% | 1.1% |
| Physical property issue | 8 | 2.5% | 1% |
| Connection problema connection problem | 6 | 1.9% | 1.2% |
| Insufficient device problem information | 4 | 1.2% | 0.6% |
| Mechanical problema mechanical problem | 3 | 0.9% | 5.6% |
| Torn material | 3 | 0.9% | 0.4% |
| Material discolored | 2 | 0.6% | 0.3% |
| Breakthe device broke | 1 | 0.3% | 2.8% |
| Defective alarm | 1 | 0.3% | 0.3% |
| Device dislodged or dislocated | 1 | 0.3% | 0.4% |
| Device displays incorrect message | 1 | 0.3% | 20.7% |
| Device issuea problem with the device | 1 | 0.3% | 0.1% |
| Failure to align | 1 | 0.3% | 0.1% |
| Leak/splashthe device leaked | 1 | 0.3% | 0.1% |
| Malposition of device | 1 | 0.3% | 0.1% |
| Material erosion | 1 | 0.3% | 0% |
| Material integrity problema problem with the device material | 1 | 0.3% | 1.2% |
| Material puncture/hole | 1 | 0.3% | 0.7% |
| Material too rigid or stiff | 1 | 0.3% | 0.2% |
| Moisture damage | 1 | 0.3% | 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 | 160 | 49.4% |
| Bacterial infectiona bacterial infection | 105 | 32.4% |
| Respiratory failurethe lungs could not supply enough oxygen | 97 | 29.9% |
| Renal failurekidney failure | 85 | 26.2% |
| Neurological deficit/dysfunction | 74 | 22.8% |
| Hemorrhage/blood loss/bleeding | 58 | 17.9% |
| Multiple organ dysfunction syndromeseveral organs failing | 45 | 13.9% |
| Liver damage/dysfunction | 30 | 9.3% |
| Fungal infectiona fungal infection | 23 | 7.1% |
| Urinary tract infectionbladder or urinary infection | 19 | 5.9% |
| Thromboembolism | 9 | 2.8% |
| Viral infectiona viral infection | 7 | 2.2% |
| Stroke/cva | 6 | 1.9% |
| Pericardial effusionfluid around the heart | 5 | 1.5% |
| Hemolysis | 3 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Syncardia 70cc Tah-T | Product code LOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 324 | 3,727 | 26,136,888 |
| Share of that pool | — | 8.7% | 0% |
| Classified as death, per 1,000 reports | 540 | 104 | 9 |
| Classified as injury | 38.6% | 8.1% | 36.2% |
| Classified as malfunction | 7.4% | 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 Temporary Total Artificial Heart Tah-T | 204 | 0 | 58.8% |
| 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 Tah-T reports
How many FDA reports name Syncardia 70cc Tah-T?
324 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 (54%), injury (38.6%) and malfunction (7.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operational issue (3.1%), physical property issue (2.5%), connection problem (1.9%), insufficient device problem information (1.2%) and mechanical problem (0.9%). 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 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.