Devices › Set, administration, intravascular
Device brand name · Set administration intravascular
ICU Medical: medical device reports filed with FDA
288 reports name it, 2004–2026. Manufacturer given most often on reports: Icu Medical. Product code FPA.
- 288
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 55
- reports, 12 months to August 2026
- 49 in the 12 months before
- 97.2%
- classified as malfunction
- 79.3% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
288 medical device reports received by FDA name the brand "ICU Medical" (set administration intravascular); the manufacturer given most often on reports is Icu Medical; received from February 2004 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
55 reports arrived in the 12 months to August 2026, up 12% 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 (97.2%), injury (0.7%) and death (0.3%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (10.8%), break (7.6%) and crack (5.6%). The patient problems coded most often are hemorrhage/blood loss/bleeding, low blood pressure/ hypotension and chemical exposure. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 349,387 reports carrying product code FPA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Fluid/blood leak | 31 | 10.8% | 13.5% |
| Breakthe device broke | 22 | 7.6% | 2.1% |
| Crackthe device cracked | 16 | 5.6% | 1.5% |
| Leak/splashthe device leaked | 15 | 5.2% | 11.2% |
| Disconnection | 12 | 4.2% | 1.8% |
| Backflow | 10 | 3.5% | 0.5% |
| Obstruction of flow | 9 | 3.1% | 0.7% |
| Defective devicethe device was defective | 8 | 2.8% | 0.2% |
| Detachment of device or device componentpart of the device came off | 8 | 2.8% | 3.9% |
| Defective component | 5 | 1.7% | 0.5% |
| Material integrity problema problem with the device material | 4 | 1.4% | 0.2% |
| Difficult to flush | 3 | 1% | 0.1% |
| Improper flow or infusion | 3 | 1% | 0.4% |
| Infusion or flow problema problem with flow or infusion | 3 | 1% | 3% |
| Material twisted/bent | 3 | 1% | 12.2% |
| Physical resistance/sticking | 3 | 1% | 0.1% |
| Air/gas in device | 2 | 0.7% | 0.9% |
| Contamination /decontamination problem | 2 | 0.7% | 0.2% |
| Device fell | 2 | 0.7% | 0% |
| Difficult to open or close | 2 | 0.7% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 10 | 3.5% |
| Low blood pressure/ hypotension | 5 | 1.7% |
| Chemical exposure | 3 | 1% |
| Exposure to body fluids | 3 | 1% |
| High blood pressure/ hypertension | 2 | 0.7% |
| Reduced blood flow | 2 | 0.7% |
| Emotional changes | 1 | 0.3% |
| Malaisegeneral feeling of being unwell | 1 | 0.3% |
| Stroke/cva | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ICU Medical | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 288 | 349,387 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 0.7% | 20% | 36.2% |
| Classified as malfunction | 97.2% | 79.3% | 62.3% |
| Filed by the manufacturer | 0.7% | 96.3% | 94.9% |
Shares are of reports, not 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."
Other brands with product code FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft Xc | 20,328 | 49 | 0% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about ICU Medical reports
How many FDA reports name ICU Medical?
288 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 55 in the latest 12 months.
What kinds of events are reported?
malfunction (97.2%), injury (0.7%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (10.8%), break (7.6%), crack (5.6%), leak/splash (5.2%) and disconnection (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (3.1%) and manufacturer reports (0.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ICU Medical was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.