Device manufacturer, as written on reports

Cpi - Del Caribe: medical device reports filed with FDA

64,617 reports name it as the manufacturer of the device involved, 2003–2023.

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.

64,617
reports naming it as manufacturer: 0.3% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 25.1%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

64,617 medical device reports received by FDA give Cpi - Del Caribe as the manufacturer of the device involved, 0.3% of the MAUDE database, from February 2003 to August 2023. 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, and none 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 (73.9%), malfunction (25.1%) and death (1%). 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
Endotak Reliance	Permanent defibrillator electrodes	20,169	238	1.2%
Ingevity	Implantable pulse generator, pacemaker (non-crt)	8,235	299	0.9%
Flextend	Permanent pacemaker electrode	4,495	203	0.7%
Easytrak 2	Drug eluting permanent left ventricular (lv) pacemaker electrode	3,678	18	0.8%
Acuity	Implantable pulse generator, pacemaker (non-crt)	2,638	6	1%
Reliance G Active Fix Dual Coil 64cm	Implantable cardioverter defibrillator (non-crt)	1,225	0	0.1%
Endotak Endurance	Permanent defibrillator electrodes	954	1	1.6%
Easytrak 3	Drug eluting permanent left ventricular (lv) pacemaker electrode	691	1	2.4%
Selute Picotip	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	672	0	0.8%
Flextend Is-1 Bi Positive Fix Ra/Rv 52 Cm	Permanent pacemaker electrode	652	0	0%
Reliance G Active Fix Dual Coil 59cm	Implantable cardioverter defibrillator (non-crt)	621	0	0%
Reliance Active Fix Dual Coil Is-1/Df-1 64cm	Implantable cardioverter defibrillator (non-crt)	592	0	0.2%
Easytrak	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	423	0	1.5%
Flextend Is-1 Bi Positive Fix Ra/Rv 59 Cm	Permanent pacemaker electrode	377	0	0%
Sweet Picotip	Permanent pacemaker electrode	317	0	1.3%
Sweet Tip	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	315	0	0.7%
Reliance Active Fix Dual Coil Is-1/Df-1 59cm	Implantable cardioverter defibrillator (non-crt)	280	0	0%
Endotak Dsp	Implantable cardioverter defibrillator (non-crt)	271	14	1.6%
Reliance Passive Dual Coil Is-1/Df-1 64cm	Permanent pacemaker electrode	260	0	0.4%
Reliance G Passive Dual Coil 64cm	Implantable cardioverter defibrillator (non-crt)	256	0	0.4%
Easytrak 2 Lva Dual Electrode Is-1 Passive 90cm	Implantable pulse generator, pacemaker (non-crt)	229	0	0%
Reliance Sg Active Fix Single Coil 64cm	Implantable cardioverter defibrillator (non-crt)	197	0	0%
Flextend Is-1 Bi Positive Fix Ra/Rv 45 Cm	Permanent pacemaker electrode	189	0	0%
Easytrak 2 Lva Dual Electrode Lv-1 Passive 90cm	Implantable pulse generator, pacemaker (non-crt)	169	0	0%
Selute	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	169	0	0.9%
Transvenous	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	162	0	0.2%
Endotak Dsp Is-1/Df-1 Tines Tri 70cm	Implantable cardioverter defibrillator (non-crt)	115	0	0%
Thinline	Permanent pacemaker electrode	4	0	1.3%

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
NVY	Permanent defibrillator electrodes	14,566	22.5%
DTB	Permanent pacemaker electrode	13,267	20.5%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	12,033	18.6%
LWS	Implantable cardioverter defibrillator (non-crt)	11,749	18.2%
LWP	Implantable pulse generator, pacemaker (non-crt)	6,657	10.3%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	4,344	6.7%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	1,887	2.9%
DTD	Pacemaker lead adaptor	53	0.1%
DXY	Implantable pacemaker pulse-generator	33	0.1%
NVZ	Pulse generator, permanent, implantable	4	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

Death1%615

Injury73.9%47,774

Malfunction25.1%16,216

Other0%6

Not given0%6

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

Questions about Cpi - Del Caribe reports

How many FDA device reports name Cpi - Del Caribe as manufacturer?

64,617 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Endotak Reliance (20,169), Ingevity (8,235), Flextend (4,495), Easytrak 2 (3,678) and Acuity (2,638).

Which device types does it report on?

permanent defibrillator electrodes (22.5%), permanent pacemaker electrode (20.5%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (18.6%) and implantable cardioverter defibrillator (non-crt) (18.2%).

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.