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FDA product code LWR · class 3 · Unknown
Heart-valve, non-allograft tissue: medical device reports filed with FDA
25,638 reports carry this product code, 1993–2026; 30 brands with a page.
- 25,638
- reports with this product code
- 0.1% of all MAUDE reports
- 2,091
- reports, 12 months to August 2026
- 1,873 in the 12 months before
- 4.9%
- classified as malfunction
- 62.3% across all reports
- 8%
- classified as death, as reported
- 0.9% across all reports
Product code LWR is FDA's classification for "Heart-valve, non-allograft tissue" (unknown panel), a class 3 device. 25,638 medical device reports carry this product code, 0.1% of the MAUDE database, from November 1993 to August 2026.
2,091 reports arrived in the 12 months to August 2026, up 12% from 1,873 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 (86.2%), death (8%) and malfunction (4.9%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Edwards Lifesciences | 7,871 | 30.7% |
| Medtronic Heart Valves Division | 4,763 | 18.6% |
| Abbott Medical | 1,419 | 5.5% |
| Medtronic Heart Valves | 1,268 | 4.9% |
| Livanova Canada | 1,262 | 4.9% |
| Medtronic Heart Valve Division | 867 | 3.4% |
| St Jude Medical Costa Rica Ltda | 711 | 2.8% |
| Baxter Healthcare | 618 | 2.4% |
| Heart Valves Santa Ana | 495 | 1.9% |
| St Jude Medical | 371 | 1.4% |
| Sorin Group Italia | 250 | 1% |
| Medtronic Mexico | 128 | 0.5% |
| Medtronic Mexico S De R L De Cv | 87 | 0.3% |
| Cryolife | 43 | 0.2% |
| Medtronic | 7 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 6,456 | 25.2% |
| Explanted | 3,275 | 12.8% |
| Gradient increase | 1,565 | 6.1% |
| Perivalvular leak | 1,527 | 6% |
| Calcified | 1,472 | 5.7% |
| Replace | 1,311 | 5.1% |
| Intravalvular regurgitation | 1,125 | 4.4% |
| Device stenosis | 1,045 | 4.1% |
| Degraded | 953 | 3.7% |
| Material split, cut or torn | 914 | 3.6% |
| Patient device interaction problem | 892 | 3.5% |
| Incomplete coaptation | 802 | 3.1% |
| Patient-device incompatibilitythe device did not suit the patient | 645 | 2.5% |
| Inadequacy of device shape and/or size | 558 | 2.2% |
| Obstruction of flow | 553 | 2.2% |
| Leak/splashthe device leaked | 529 | 2.1% |
| Tears, rips, holes in device, device material | 447 | 1.7% |
| Other (for use when an appropriate device code cannot be identified) | 422 | 1.6% |
| Backflow | 378 | 1.5% |
| Fluid/blood leak | 342 | 1.3% |
Questions about heart-valve, non-allograft tissue reports
What is product code LWR?
FDA's classification code for "Heart-valve, non-allograft tissue", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
25,638 reports through August 2026, 2,091 of them in the latest 12 months.
Which brands appear most often?
Freestyle Aortic Root Bioprosthesis (2,341), Edwards INSPIRIS RESILIA Aortic Valve (2,001), Sjm Trifecta Valve (1,525), Perceval Sutureless Aortic Heart Valve (1,406) and Mosaic Aortic Bioprosthetic Heart Valve (1,285). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.