Device manufacturer, as written on reports

Datascope: medical device reports filed with FDA

29,477 reports name it as the manufacturer of the device involved, 1992–2026.

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.

29,477
reports naming it as manufacturer: 0.1% of all MAUDE reports; 7,719
reports, 12 months to August 2026: 6,221 in the 12 months before; 93%
classified as malfunction: 62.3% across all reports; 2.3%
classified as death, as reported: 0.9% across all reports

29,477 medical device reports received by FDA give Datascope as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

7,719 reports arrived in the 12 months to August 2026, up 24% from 6,221 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 malfunction (93%), injury (4.1%) and death (2.3%). 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
Cardiosave Hybrid Type B Plug	System, balloon, intra-aortic and control	6,509	2,631	0.4%
System 97	System, balloon, intra-aortic and control	1,654	0	1.7%
CS300 Intra-Aortic Balloon Pump, English, 110V	System, balloon, intra-aortic and control	1,300	466	0.3%
Cardiosave Hybrid W/ E/F Plug	System, balloon, intra-aortic and control	1,198	402	0.3%
Cardiosave Hybrid Type I Plug	System, balloon, intra-aortic and control	1,101	485	0.1%
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)	System, balloon, intra-aortic and control	982	491	1.4%
Stat Dl 9 5 Fr 40 Cc Iab	System, balloon, intra-aortic and control	904	0	3%
Cardiosave Hybrid Type G Plug	System, balloon, intra-aortic and control	891	317	0.4%
Percor Stat Dl 9 5 Fr 40 Cc Iab	System, balloon, intra-aortic and control	776	0	1.3%
Cs300	System, balloon, intra-aortic and control	748	3	1.9%
CS300 Intra-Aortic Balloon Pump, English, 220V	System, balloon, intra-aortic and control	703	207	0.2%
System 90	System, balloon, intra-aortic and control	697	0	0.6%
CS100 Intra-Aortic Balloon Pump, Chinese, 220V	System, balloon, intra-aortic and control	660	223	0.1%
CS100 Intra-Aortic Balloon Pump, English, 220V	System, balloon, intra-aortic and control	572	159	0.4%
Cardiosave Hybrid 3 1 Edition	System, balloon, intra-aortic and control	556	245	0.6%
Cs100	System, balloon, intra-aortic and control	502	0	3.7%
System 90t	System, balloon, intra-aortic and control	431	0	1.2%
Intra-Aortic Balloon Catheter	System, balloon, intra-aortic and control	406	0	3.9%
System 98	System, balloon, intra-aortic and control	389	0	3%
Stat Dl 9 5 Fr 34 Cc Iab	System, balloon, intra-aortic and control	307	0	2.9%
System 97e	System, balloon, intra-aortic and control	298	0	1.3%
SENSATION PLUS 7.5Fr. 40cc IAB & Accessories	System, balloon, intra-aortic and control	254	123	1.6%
Cardiosave Hybrid Type D Plug	System, balloon, intra-aortic and control	251	131	0.7%
Percor Stat Dl 9 5 Fr 34 Cc Iab	System, balloon, intra-aortic and control	239	0	0.8%
CS300 Intra-Aortic Balloon Pump, Chinese, 220V	System, balloon, intra-aortic and control	224	83	0.4%
Datascope	System, balloon, intra-aortic and control	223	0	7.3%
CS300 Intra-Aortic Balloon Pump, Japanese, 110V	System, balloon, intra-aortic and control	221	52	1.1%
TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES	System, balloon, intra-aortic and control	197	92	1%
TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES	System, balloon, intra-aortic and control	197	99	1%
CS100 Intra-Aortic Balloon Pump, English, 110V	System, balloon, intra-aortic and control	184	46	0.3%

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
DSP	System, balloon, intra-aortic and control	28,742	97.5%
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	139	0.5%
DWE	Tubing, pump, cardiopulmonary bypass	113	0.4%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	90	0.3%
DYB	Introducer, catheter	76	0.3%
DRT	Monitor, cardiac (incl. cardiotachometer & rate alarm)	66	0.2%
GEI	Electrosurgical, cutting & coagulation & accessories	43	0.1%
MGB	Device, hemostasis, vascular	36	0.1%
DTZ	Oxygenator, cardiopulmonary bypass	28	0.1%
LDD	Dc-defibrillator, low-energy, (including paddles)	28	0.1%

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

Death2.3%691

Injury4.1%1,199

Malfunction93%27,422

Other0.2%73

Not given0.3%92

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

Questions about Datascope reports

How many FDA device reports name Datascope as manufacturer?

29,477 reports through August 2026, 7,719 of them in the latest 12 months.

Which of its brands appear most often?

Cardiosave Hybrid Type B Plug (6,509), System 97 (1,654), CS300 Intra-Aortic Balloon Pump, English, 110V (1,300), Cardiosave Hybrid W/ E/F Plug (1,198) and Cardiosave Hybrid Type I Plug (1,101).

Which device types does it report on?

system, balloon, intra-aortic and control (97.5%), monitor, physiological, patient(with arrhythmia detection or alarms) (0.5%), tubing, pump, cardiopulmonary bypass (0.4%) and catheter, cannula and tubing, vascular, cardiopulmonary bypass (0.3%).

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.