Temporary non-roller type left heart support blood pump: medical device reports filed with FDA

45,326 reports carry this product code, 2016–2026; 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.

45,326
reports with this product code: 0.2% of all MAUDE reports; 14,994
reports, 12 months to August 2026: 13,009 in the 12 months before; 38%
classified as malfunction: 62.3% across all reports; 12.8%
classified as death, as reported: 0.9% across all reports

Product code OZD is FDA's classification for "Temporary non-roller type left heart support blood pump" (unknown panel), a class 3 device. 45,326 medical device reports carry this product code, 0.2% of the MAUDE database, from February 2016 to August 2026.

14,994 reports arrived in the 12 months to August 2026, up 15% from 13,009 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 (49.2%), malfunction (38%) and death (12.8%). 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
Impella CP	20,560	2,463	12.9%	27.8%
Impella	7,952	8,251	15.2%	40.4%
Impella 5.5	7,578	1,640	12.5%	41.7%
Automated Impella Controller	3,740	455	5.6%	93.4%
Pump 381 Pump Set (US)	795	795	26.2%	9.9%
Impella 5 0	624	3	22.3%	32.8%
Impella 5.5 with SmartAssist S2 Set, US	578	578	19.6%	18.9%
Impella 2 5	320	0	11.9%	33%
Impella Cp Optical	248	0	8.1%	5.6%
Automated Impella Controller Aic	222	0	3.6%	95.1%
Pump 371 14f Lt Cmr Set	210	210	23.3%	14.8%
Impella Cp Pump	180	0	5%	9.9%
Impella Cp Pump Set	165	0	3.6%	1.2%
Purge Cassette Gen 2, Sterile, Non QSK	159	183	8.7%	83.1%
Kit, 14Fr Introducer, 13cm&25cm, Sterile	32	396	8.7%	30.7%
Impella RP Flex	13	173	19.5%	34.9%
Impella Rp	5	94	14.9%	42%

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
Abiomed	34,727	76.6%
Abiomed - 1220648	10,177	22.5%

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

Death12.8%5,797

Injury49.2%22,309

Malfunction38%17,218

Other0%2

Not given0%0

Who filed

Manufacturer report99.6%45,127

Voluntary report0.2%78

User facility report0%0

Distributor report0%0

Not given0.3%121

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device sensing problem	3,151	7%
Restricted flow rate	3,116	6.9%
Patient device interaction problem	2,873	6.3%
Patient-device incompatibilitythe device did not suit the patient	2,043	4.5%
Pumping stopped	1,804	4%
Malposition of device	1,709	3.8%
Failure to advance	1,688	3.7%
Application program problem	1,552	3.4%
Increase in pressure	1,542	3.4%
Positioning failure	1,486	3.3%
Fluid/blood leak	1,095	2.4%
Deformation due to compressive stress	996	2.2%
Electrical /electronic property probleman electrical or electronic problem	921	2%
Failure to read input signal	840	1.9%
Battery problema problem with the battery	711	1.6%
Activation, positioning or separation problem	605	1.3%
Improper flow or infusion	492	1.1%
Positioning problem	491	1.1%
Material integrity problema problem with the device material	465	1%
Priming problem	412	0.9%

Questions about temporary non-roller type left heart support blood pump reports

What is product code OZD?

FDA's classification code for "Temporary non-roller type left heart support blood pump", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

45,326 reports through August 2026, 14,994 of them in the latest 12 months.

Which brands appear most often?

Impella CP (20,560), Impella (7,952), Impella 5.5 (7,578), Automated Impella Controller (3,740) and Pump 381 Pump Set (US) (795). 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.