Ring, annuloplasty: medical device reports filed with FDA

9,698 reports carry this product code, 1994–2026; 17 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.

9,698
reports with this product code: 0% of all MAUDE reports; 445
reports, 12 months to August 2026: 422 in the 12 months before; 2.2%
classified as malfunction: 62.3% across all reports; 8.1%
classified as death, as reported: 0.9% across all reports

Product code KRH is FDA's classification for "Ring, annuloplasty" (cardiovascular panel), a class 2 device. 9,698 medical device reports carry this product code, 0% of the MAUDE database, from June 1994 to August 2026.

445 reports arrived in the 12 months to August 2026, close to the 422 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 (88%), death (8.1%) and malfunction (2.2%). 17 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
Carpentier-Edwards Physio Annuloplasty Ring	1,495	0	7.8%	0.5%
Cosgrove-Edwards Annuloplasty System	1,114	2	6.6%	0.7%
CG Future Band	1,064	131	1.1%	3.1%
Carpentier-Edwards Classic Annuloplasty Ring	804	0	10%	0%
Edwards Mc3 Tricuspid Annuloplasty System	379	0	50.4%	0.8%
Simulus Semi-Rigid Annulopasty Ring	235	13	0.4%	1.7%
Simulus Fully Flexible Annuloplasty Band	228	13	0.9%	0%
Cosgrove-Edwards Annuloplasty System With Duraflo Treatment	220	0	9.9%	0%
Carpentier-Edwards Physio Annuloplasty Ring With Duraflo Treatment	164	0	23.4%	0%
Simuplus	164	49	1.2%	1.8%
Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis	3	18	8.7%	1.8%
Carpentier-Edwards Perimount Magna Aortic Bioprosthesis	2	11	27.1%	1.8%
Carpentier-Edwards Perimount Pericardial Bioprosthesis	2	1	10%	0.6%
Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis	2	13	3.3%	1.8%
Carpentier-Edwards Bioprosthesis	1	3	5%	0.6%
Carpentier-Edwards Perimount Aortic Pericardial Bioprosthesis	1	7	7.1%	3.2%
Edwards Pericardial Patch	1	0	83.7%	9.5%

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
Edwards Lifesciences	4,764	49.1%
Medtronic Heart Valves Division	2,466	25.4%
Baxter Healthcare	519	5.4%
Medtronic Heart Valve Division	392	4%
Medtronic Mexico S De R L De Cv	293	3%
Medtronic Mexico	232	2.4%
Sorin Group Italia	136	1.4%
Heart Valves Santa Ana	111	1.1%
Medtronic Heart Valves	52	0.5%
St Jude Medical Puerto Rico	49	0.5%
St Jude Medical	16	0.2%

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

Death8.1%781

Injury88%8,538

Malfunction2.2%209

Other1.5%148

Not given0.2%22

Who filed

Manufacturer report98.7%9,573

Voluntary report0.3%27

User facility report0%0

Distributor report0.6%61

Not given0.4%37

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	2,465	25.4%
Explanted	1,621	16.7%
Patient device interaction problem	387	4%
Replace	357	3.7%
Intravalvular regurgitation	254	2.6%
Inadequacy of device shape and/or size	222	2.3%
Perivalvular leak	126	1.3%
Deterioration of prosthesis	119	1.2%
Valve(s), failure of	111	1.1%
Other (for use when an appropriate device code cannot be identified)	88	0.9%
Reflux within device	72	0.7%
Device operates differently than expectedthe device behaved unexpectedly	69	0.7%
Material separation	60	0.6%
Incomplete coaptation	56	0.6%
Lack of effect	52	0.5%
Leak/splashthe device leaked	49	0.5%
Gradient increase	48	0.5%
Device issuea problem with the device	34	0.4%
Device stenosis	34	0.4%
Patient-device incompatibilitythe device did not suit the patient	32	0.3%

Questions about ring, annuloplasty reports

What is product code KRH?

FDA's classification code for "Ring, annuloplasty", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

9,698 reports through August 2026, 445 of them in the latest 12 months.

Which brands appear most often?

Carpentier-Edwards Physio Annuloplasty Ring (1,495), Cosgrove-Edwards Annuloplasty System (1,114), CG Future Band (1,064), Carpentier-Edwards Classic Annuloplasty Ring (804) and Edwards Mc3 Tricuspid Annuloplasty System (379). 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.