Devices › Heart-valve, mechanical
Device brand name · Mechanical heart valve
Medtronic Hall Prosthetic Heart Valve: medical device reports filed with FDA
207 reports name it, 1996–2024. Manufacturer given most often on reports: Medtronic Heart Valves. Product code LWQ.
- 207
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 32.4%
- classified as malfunction
- 10.3% across the product code
- 19.8%
- classified as death, as reported
- 41 reports · not verified by FDA
207 medical device reports received by FDA name the brand "Medtronic Hall Prosthetic Heart Valve" (mechanical heart valve); the manufacturer given most often on reports is Medtronic Heart Valves; received from September 1996 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 injury (47.8%), malfunction (32.4%) and death (19.8%); across all heart-valve, mechanical reports (product code LWQ) death is recorded in 12.7% and malfunction in 10.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (32.9%), explanted (29.5%) and sticking (11.1%). The patient problems coded most often are surgical procedure, repeated, surgery, prolonged and aortic valve replacement. 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 7,097 reports carrying product code LWQ. 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 |
|---|---|---|---|
| Replace | 68 | 32.9% | 18% |
| Explanted | 61 | 29.5% | 24.9% |
| Sticking | 23 | 11.1% | 2.2% |
| Obstruction of flow | 21 | 10.1% | 3.1% |
| Device remains implanted | 15 | 7.2% | 2.7% |
| Other (for use when an appropriate device code cannot be identified) | 13 | 6.3% | 2.2% |
| Valve(s), failure of | 13 | 6.3% | 2.6% |
| Gradient increase | 6 | 2.9% | 2.3% |
| Difficult to position | 5 | 2.4% | 0.3% |
| Entrapment of device | 5 | 2.4% | 0.4% |
| Perivalvular leak | 5 | 2.4% | 4.8% |
| Valve(s), sticking | 5 | 2.4% | 0.9% |
| Difficult to removethe device was hard to remove | 4 | 1.9% | 0.2% |
| Improper or incorrect procedure or method | 4 | 1.9% | 0.6% |
| Failure, intermittent | 3 | 1.4% | 0.1% |
| Implant, removal of | 3 | 1.4% | 1.9% |
| Crackthe device cracked | 2 | 1% | 0% |
| Device issuea problem with the device | 2 | 1% | 0.4% |
| Difficult to insertthe device was hard to insert | 2 | 1% | 0.3% |
| Method, improper/incorrect | 2 | 1% | 0% |
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 |
|---|---|---|
| Surgical procedure, repeated | 39 | 18.8% |
| Surgery, prolonged | 28 | 13.5% |
| Aortic valve replacement | 22 | 10.6% |
| Deaththe patient died; cause not stated by this term | 21 | 10.1% |
| Surgical procedure | 14 | 6.8% |
| Therapy/non-surgical treatment, additional | 14 | 6.8% |
| Corneal pannus | 12 | 5.8% |
| Other (for use when an appropriate patient code cannot be identified) | 12 | 5.8% |
| Mitral valve replacement | 11 | 5.3% |
| Thrombus | 11 | 5.3% |
| Surgical procedure, additional | 9 | 4.3% |
| Cardiac arrestthe heart stopped | 5 | 2.4% |
| Aortic insufficiency | 4 | 1.9% |
| Failure of implant | 3 | 1.4% |
| Hemolysis | 3 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Medtronic Hall Prosthetic Heart Valve | Product code LWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 207 | 7,097 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 198 | 127 | 9 |
| Classified as injury | 47.8% | 75.7% | 36.2% |
| Classified as malfunction | 32.4% | 10.3% | 62.3% |
| Filed by the manufacturer | 98.6% | 92.6% | 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 LWQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Aortic Ap | 409 | 44 | 2.7% |
| Standard Cuff | 329 | 0 | 10.6% |
| Regent Heart Valve with Flex Cuff | 268 | 65 | 5.2% |
| Sjm Masters Series Mechanical Heart Valve | 259 | 0 | 12.4% |
| Sjm Regent Heart Valve W/Flex Cuff | 246 | 0 | 13% |
| Open Pivot Mechanical Heart Valve | 222 | 12 | 5% |
| Sjm Mechanical Heart Valve | 178 | 0 | 7.9% |
| Bjork-Shiley 60 Degree Convexo-Concave | 165 | 0 | 27.3% |
| Trifecta | 227 | 115 | 8.8% |
| Mosaic Aortic Bioprosthetic Heart Valve | 3,406 | 405 | 2.8% |
| Trifecta Stented Tissue Valve | 290 | 0 | 7.9% |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis | 978 | 1 | 10% |
| Shiley | 12,236 | 1,513 | 1.1% |
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 Medtronic Hall Prosthetic Heart Valve reports
How many FDA reports name Medtronic Hall Prosthetic Heart Valve?
207 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?
injury (47.8%), malfunction (32.4%) and death (19.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (32.9%), explanted (29.5%), sticking (11.1%), obstruction of flow (10.1%) and device remains implanted (7.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Medtronic Hall Prosthetic Heart Valve 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.