Heart-valve, mechanical: medical device reports filed with FDA

7,097 reports carry this product code, 1992–2026; 14 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

7,097
reports with this product code: 0% of all MAUDE reports; 376
reports, 12 months to August 2026: 361 in the 12 months before; 10.3%
classified as malfunction: 62.3% across all reports; 12.7%
classified as death, as reported: 0.9% across all reports

Product code LWQ is FDA's classification for "Heart-valve, mechanical" (unknown panel), a class 3 device. 7,097 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

376 reports arrived in the 12 months to August 2026, close to the 361 of 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 (75.7%), death (12.7%) and malfunction (10.3%). 14 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Aortic Ap	409	44	2.7%	5.6%
Standard Cuff	329	0	10.6%	0.3%
Regent Heart Valve with Flex Cuff	268	65	5.2%	66%
Sjm Masters Series Mechanical Heart Valve	257	0	12.4%	2.7%
Sjm Regent Heart Valve W/Flex Cuff	238	0	13%	10.2%
Open Pivot Mechanical Heart Valve	222	12	5%	6.3%
Medtronic Hall Prosthetic Heart Valve	191	0	19.8%	32.4%
Sjm Mechanical Heart Valve	177	0	7.9%	2.2%
Bjork-Shiley 60 Degree Convexo-Concave	165	0	27.3%	5.5%
Trifecta	10	115	8.8%	16.7%
Mosaic Aortic Bioprosthetic Heart Valve	2	405	2.8%	8.4%
Trifecta Stented Tissue Valve	2	0	7.9%	1.4%
Carpentier-Edwards Perimount Pericardial Bioprosthesis	1	1	10%	0.6%
Shiley	1	1,513	1.1%	74.5%

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
St Jude Medical Puerto Rico	1,165	16.4%
St Jude Medical	998	14.1%
Abbott Medical	256	3.6%
Sorin Group Italia	256	3.6%
Medtronic	210	3%
Medtronic Heart Valves Division	205	2.9%
Medtronic Heart Valves	149	2.1%
Medtronic Heart Valve Division	79	1.1%
Edwards Lifesciences	23	0.3%
Cryolife	14	0.2%
Heart Valves Santa Ana	13	0.2%
St Jude Medical Costa Rica Ltda	3	0%
St Jude Medical Crmd	3	0%
Livanova Canada	2	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

Death12.7%903

Injury75.7%5,375

Malfunction10.3%731

Other0.7%47

Not given0.6%41

Who filed

Manufacturer report92.6%6,573

Voluntary report2.5%179

User facility report0%0

Distributor report1.5%103

Not given3.4%242

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Explanted	1,765	24.9%
Replace	1,278	18%
Insufficient device problem information	1,024	14.4%
Incomplete coaptation	369	5.2%
Perivalvular leak	341	4.8%
Paravalvular leak(s)	289	4.1%
Fracturea broken bone	253	3.6%
Obstruction of flow	220	3.1%
Physical resistance/sticking	210	3%
Patient device interaction problem	201	2.8%
Inadequacy of device shape and/or size	195	2.7%
Device remains implanted	190	2.7%
Valve(s), failure of	181	2.6%
Gradient increase	161	2.3%
Other (for use when an appropriate device code cannot be identified)	154	2.2%
Sticking	154	2.2%
Leak/splashthe device leaked	148	2.1%
Implant, removal of	136	1.9%
Detachment of device or device componentpart of the device came off	113	1.6%
Device operates differently than expectedthe device behaved unexpectedly	103	1.5%

Questions about heart-valve, mechanical reports

What is product code LWQ?

FDA's classification code for "Heart-valve, mechanical", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,097 reports through August 2026, 376 of them in the latest 12 months.

Which brands appear most often?

Aortic Ap (409), Standard Cuff (329), Regent Heart Valve with Flex Cuff (268), Sjm Masters Series Mechanical Heart Valve (257) and Sjm Regent Heart Valve W/Flex Cuff (238). 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.