Device brand name · External pneumatic driver
Syncardia Companion 2 Driver: medical device reports filed with FDA
848 reports name it, 2012–2026. Manufacturer given most often on reports: Syncardia Systems. Product code LOZ.
- 848
- device reports naming the brand
- 0% of all MAUDE reports · about 61 a year
- 5
- reports, 12 months to August 2026
- 15 in the 12 months before
- 96.3%
- classified as malfunction
- 81.1% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
848 medical device reports received by FDA name the brand "Syncardia Companion 2 Driver" (external pneumatic driver); the manufacturer given most often on reports is Syncardia Systems; received from July 2012 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
5 reports arrived in the 12 months to August 2026, down 67% from 15 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 malfunction (96.3%), injury (3.1%) and death (0.4%); 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 displays incorrect message (29.6%), audible prompt/feedback problem (22.1%) and device operates differently than expected (17.6%). The patient problems coded most often are no patient involvement, hemolysis and loss of consciousness. 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 displays incorrect message | 251 | 29.6% | 20.7% |
| Audible prompt/feedback problem | 187 | 22.1% | 16% |
| Device operates differently than expectedthe device behaved unexpectedly | 149 | 17.6% | 10.2% |
| Battery problema problem with the battery | 80 | 9.4% | 8.7% |
| Noise, audible | 73 | 8.6% | 6.6% |
| Mechanical problema mechanical problem | 48 | 5.7% | 5.6% |
| Electrical /electronic property probleman electrical or electronic problem | 37 | 4.4% | 3.7% |
| Display or visual feedback problem | 31 | 3.7% | 2.1% |
| Output problem | 29 | 3.4% | 3.1% |
| Failure to charge | 20 | 2.4% | 2.4% |
| Power problem | 20 | 2.4% | 2.6% |
| No display/image | 12 | 1.4% | 1.1% |
| Pressure problem | 11 | 1.3% | 0.3% |
| Device operational issue | 10 | 1.2% | 1.1% |
| Device inoperablethe device could not be used | 9 | 1.1% | 1.2% |
| Breakthe device broke | 6 | 0.7% | 2.8% |
| Device stops intermittentlythe device stopped now and then | 6 | 0.7% | 0.5% |
| Image display error/artifact | 6 | 0.7% | 0.7% |
| Application interface becomes non-functional or program exits abnormally | 5 | 0.6% | 0.2% |
| Computer operating system problem | 5 | 0.6% | 0.8% |
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 |
|---|---|---|
| No patient involvement | 227 | 26.8% |
| Hemolysis | 10 | 1.2% |
| Loss of consciousnesspassing out | 9 | 1.1% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0.5% |
| Complaint, ill-defined | 3 | 0.4% |
| Deaththe patient died; cause not stated by this term | 3 | 0.4% |
| Low cardiac output | 3 | 0.4% |
| Right ventricular failure | 3 | 0.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.2% |
| Edemaswelling from fluid | 2 | 0.2% |
| High blood pressure/ hypertension | 2 | 0.2% |
| Pulmonary edema | 2 | 0.2% |
| Renal failurekidney failure | 2 | 0.2% |
| Decreased respiratory rate | 1 | 0.1% |
| Device embedded in tissue or plaque | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Syncardia Companion 2 Driver | Product code LOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 848 | 3,727 | 26,136,888 |
| Share of that pool | — | 22.8% | 0% |
| Classified as death, per 1,000 reports | 4 | 104 | 9 |
| Classified as injury | 3.1% | 8.1% | 36.2% |
| Classified as malfunction | 96.3% | 81.1% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 70cc Tah-T | 324 | 0 | 54% |
| 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 Companion 2 Driver reports
How many FDA reports name Syncardia Companion 2 Driver?
848 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
malfunction (96.3%), injury (3.1%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (29.6%), audible prompt/feedback problem (22.1%), device operates differently than expected (17.6%), battery problem (9.4%) and noise, audible (8.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Syncardia Companion 2 Driver 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.