Device manufacturer, as written on reports

Abiomed: medical device reports filed with FDA

37,141 reports name it as the manufacturer of the device involved, 1996–2026.

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.

37,141
reports naming it as manufacturer: 0.1% of all MAUDE reports; 5,300
reports, 12 months to August 2026: 13,991 in the 12 months before; 39.1%
classified as malfunction: 62.3% across all reports; 12.1%
classified as death, as reported: 0.9% across all reports

37,141 medical device reports received by FDA give Abiomed as the manufacturer of the device involved, 0.1% of the MAUDE database, from August 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5,300 reports arrived in the 12 months to August 2026, down 62% from 13,991 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 (48.8%), malfunction (39.1%) and death (12.1%). 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
Impella CP	Temporary non-roller type left heart support blood pump	20,071	2,463	12.9%
Impella 5.5	Temporary non-roller type left heart support blood pump	7,295	1,640	12.5%
Automated Impella Controller	Temporary non-roller type left heart support blood pump	3,740	455	5.6%
Impella Rp	Temporary non-roller type right heart support blood pump	1,103	94	14.9%
Impella	Temporary non-roller type left heart support blood pump	769	8,251	15.2%
Impella 5 0	Temporary non-roller type left heart support blood pump	602	3	22.3%
Impella RP Flex	Temporary non-roller type right heart support blood pump	540	173	19.5%
Impella 2 5	Temporary non-roller type left heart support blood pump	302	0	11.9%
Impella Cp Optical	Temporary non-roller type left heart support blood pump	244	0	8.1%
Automated Impella Controller Aic	Temporary non-roller type left heart support blood pump	222	0	3.6%
Impella Cp Pump	Temporary non-roller type left heart support blood pump	162	0	5%
Impella Cp Pump Set	Temporary non-roller type left heart support blood pump	158	0	3.6%
Kit, 14Fr Introducer, 13cm&25cm, Sterile	Introducer, catheter	117	396	8.7%
Pump 381 Pump Set (US)	Temporary non-roller type left heart support blood pump	86	795	26.2%
Impella 5.5 with SmartAssist S2 Set, US	Temporary non-roller type left heart support blood pump	61	578	19.6%
Purge Cassette Gen 2, Sterile, Non QSK	Temporary non-roller type left heart support blood pump	40	183	8.7%
Pump 371 14f Lt Cmr Set	Temporary non-roller type left heart support blood pump	16	210	23.3%

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
OZD	Temporary non-roller type left heart support blood pump	34,727	93.5%
PYX	Temporary non-roller type right heart support blood pump	1,742	4.7%
DSQ	Ventricular (assist) bypass	251	0.7%
DYB	Introducer, catheter	212	0.6%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	100	0.3%
DQX	Wire, guide, catheter	17	0%
DTZ	Oxygenator, cardiopulmonary bypass	12	0%
DWA	Control, pump speed, cardiopulmonary bypass	4	0%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	3	0%
DSP	System, balloon, intra-aortic and control	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

Death12.1%4,479

Injury48.8%18,129

Malfunction39.1%14,522

Other0%6

Not given0%5

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

Questions about Abiomed reports

How many FDA device reports name Abiomed as manufacturer?

37,141 reports through August 2026, 5,300 of them in the latest 12 months.

Which of its brands appear most often?

Impella CP (20,071), Impella 5.5 (7,295), Automated Impella Controller (3,740), Impella Rp (1,103) and Impella (769).

Which device types does it report on?

temporary non-roller type left heart support blood pump (93.5%), temporary non-roller type right heart support blood pump (4.7%), ventricular (assist) bypass (0.7%) and introducer, catheter (0.6%).

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.