Device manufacturer, as written on reports

St Jude Medical Costa Rica Ltda: medical device reports filed with FDA

1,822 reports name it as the manufacturer of the device involved, 2013–2025.

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.

1,822
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 29 in the 12 months before; 26.5%
classified as malfunction: 62.3% across all reports; 5.4%
classified as death, as reported: 0.9% across all reports

1,822 medical device reports received by FDA give St Jude Medical Costa Rica Ltda as the manufacturer of the device involved, 0% of the MAUDE database, from April 2013 to May 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, against 29 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 (68.1%), malfunction (26.5%) and death (5.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Sjm Trifecta Valve	Heart-valve, non-allograft tissue	363	0	8.1%
TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	292	38	2.4%
Trifecta GT Valve	Heart-valve, non-allograft tissue	167	66	9.5%
Trifecta Stented Tissue Valve	Heart-valve, non-allograft tissue	106	0	7.9%
Pressurewire X Wireless Rx 175cm	Wire, guide, catheter	87	0	1.3%
Agilis NxT Steerable Introducer Dual-Reach 61 cm Sheath, Small Curl Dual-Reach	Introducer, catheter	53	53	0.3%
Inquiry Steerable Diagnostic Catheter	Catheter, electrode recording, or probe, electrode recording	45	8	3.9%
Agilis NxT Steerable Introducer Dual-Reach 71 cm Sheath, Small Curl, 8.5F	Introducer, catheter	43	20	1.4%
Agilis NxT Steerable Introducer Dual-Reach 71 cm Sheath, Medium Curl, 8.5 F	Introducer, catheter	40	41	2.3%
Epic Stented Porcine Heart Valve W/Flexfit System	Heart-valve, non-allograft tissue	38	0	7.1%
Transseptal Needle, BRK Series	Trocar	36	32	5.9%
Flexability Ablation Catheter Sensor Enabled	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	28	9	9%
TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve F	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	19	4	4%
ViewFlex Xtra ICE Catheter	Catheter, ultrasound, intravascular	19	66	1.2%
TactiFlex Ablation Catheter, Sensor Enabled	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	17	164	3.7%
TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve F-J	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	14	6	2.7%
PressureWire	Transducer, pressure, catheter tip	11	80	1.8%
TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve D	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	11	11	1.6%
Agilis Nxt Steerable Introducer Dual-Reach 71 Cm Sheath Large Curl 8 5f	Introducer, catheter	10	17	1.3%
Amplatzer Septal Occluder	Transcatheter septal occluder	4	406	2.4%
Advisor HD Grid Mapping Catheter, Sensor Enabled	Catheter, electrode recording, or probe, electrode recording	1	32	3.3%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
LWR	Heart-valve, non-allograft tissue	711	39%
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	385	21.1%
DYB	Introducer, catheter	188	10.3%
DRC	Trocar	140	7.7%
DXO	Transducer, pressure, catheter tip	113	6.2%
DRF	Catheter, electrode recording, or probe, electrode recording	91	5%
DQX	Wire, guide, catheter	68	3.7%
OAD	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	50	2.7%
NPT	Aortic valve, prosthesis, percutaneously delivered	24	1.3%
OBJ	Catheter, ultrasound, intravascular	18	1%

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

Death5.4%99

Injury68.1%1,240

Malfunction26.5%483

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about St Jude Medical Costa Rica Ltda reports

How many FDA device reports name St Jude Medical Costa Rica Ltda as manufacturer?

1,822 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Sjm Trifecta Valve (363), TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F (292), Trifecta GT Valve (167), Trifecta Stented Tissue Valve (106) and Pressurewire X Wireless Rx 175cm (87).

Which device types does it report on?

heart-valve, non-allograft tissue (39%), catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation (21.1%), introducer, catheter (10.3%) and trocar (7.7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.