Device manufacturer, as written on reports

Hospira: medical device reports filed with FDA

8,409 reports name it as the manufacturer of the device involved, 2004–2025.

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.

8,409
reports naming it as manufacturer: 0% of all MAUDE reports; 14
reports, 12 months to August 2026: 49 in the 12 months before; 89.2%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

8,409 medical device reports received by FDA give Hospira as the manufacturer of the device involved, 0% of the MAUDE database, from February 2004 to December 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

14 reports arrived in the 12 months to August 2026, down 71% from 49 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 (89.2%), injury (7%) and other (2.2%). 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
Pca Empty Sterile	Pump, infusion, pca	332	0	0%
Plum Xlmd Pump	Pump, infusion	260	0	0%
Acclaim Encore	Pump, infusion	218	0	0.2%
Plum A+ Pump	Pump, infusion	211	0	1.8%
Lifecare Pca Plus Infuser	Pump, infusion, pca	166	0	6.9%
Plum Xlm Single Chan	Pump, infusion	165	0	0.6%
Gemstr 7 Thpy Alt St	Pump, infusion	161	0	0%
Gemstar Boluscord Each	Pump, infusion	158	0	0%
Gemstar 7 Therapy Pump	Pump, infusion	157	0	0%
Lslf Ext Set W Clv	Set, administration, intravascular	153	0	0%
Lifeshield Primary Piggyback Set Nv	Set, administration, intravascular	111	0	0%
Symbiq Dual Channel	Pump, infusion	102	0	0.1%
Lifeshield Nv Primary Piggyback Set	Set, administration, intravascular	99	0	0.5%
Omni-Flow Model 4000 Plus	Pump, infusion	95	0	1.8%
Symbiq Single Channe	Pump, infusion	84	0	0.1%
Acclaim Encore 2 25	Pump, infusion	68	0	0%
Abbott Ambulatory Infusion-Aim Plus Pump	Pump, infusion	64	0	1.9%
Lifecare Plum Pump Model 5000	Pump, infusion	63	0	0.9%
Plum Xl Micro/Macro Pump	Pump, infusion	49	0	1.1%
Plum A+ Driver New 8	Pump, infusion	47	0	0.5%
Plum A+	Set, administration, intravascular	44	0	1.4%
Plum Xl3m Micro/Macro Pump	Pump, infusion	43	0	0.6%
Plma Dvc V11 51 1 N	Pump, infusion	39	0	0%
Gemstar Pain Mge Sng	Pump, infusion	35	0	0%
Lifecare Pca 3 V5 06	Pump, infusion, pca	34	0	1.9%
Plum Xlm W/Dataport	Pump, infusion	33	0	0.2%
Plum Xlm W/Modifd B	Pump, infusion	31	0	0%
Symbiq Single Channel	Pump, infusion	24	0	0%
Alaris	Pump, infusion	2	79	1.1%

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
FRN	Pump, infusion	4,209	50.1%
FPA	Set, administration, intravascular	2,366	28.1%
MEA	Pump, infusion, pca	942	11.2%
FPK	Tubing, fluid delivery	309	3.7%
KPE	Container, i.v.	126	1.5%
KDQ	Bottle, collection, vacuum	113	1.3%
GCX	Apparatus, suction, operating-room, wall vacuum powered	87	1%
DRS	Transducer, blood-pressure, extravascular	72	0.9%
FPB	Filter, infusion line	42	0.5%
FMF	Syringe, piston	26	0.3%

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

Death0.9%73

Injury7%587

Malfunction89.2%7,497

Other2.2%181

Not given0.8%71

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

Questions about Hospira reports

How many FDA device reports name Hospira as manufacturer?

8,409 reports through August 2026, 14 of them in the latest 12 months.

Which of its brands appear most often?

Pca Empty Sterile (332), Plum Xlmd Pump (260), Acclaim Encore (218), Plum A+ Pump (211) and Lifecare Pca Plus Infuser (166).

Which device types does it report on?

pump, infusion (50.1%), set, administration, intravascular (28.1%), pump, infusion, pca (11.2%) and tubing, fluid delivery (3.7%).

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.