Devices › Pump, infusion, implanted, programmable
Device brand name · Catheter
Catheter: medical device reports filed with FDA
244 reports name it, 1994–2026. Manufacturer given most often on reports: I-Flow. Product code LKK.
- 244
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 9
- reports, 12 months to August 2026
- 9 in the 12 months before
- 27.9%
- classified as malfunction
- 32.6% across the product code
- 3.7%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 244 reports that name the brand "Catheter" (catheter), received between March 1994 and August 2026; the manufacturer given most often on reports is I-Flow. Spellings of one product vary from report to report.
9 reports arrived in the 12 months to August 2026, close to the 9 of 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 (60.7%), malfunction (27.9%) and other (6.1%); across all pump, infusion, implanted, programmable reports (product code LKK) death is recorded in 1.4% and malfunction in 32.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (6.1%), break (5.3%) and malposition of device (4.9%). The patient problems coded most often are pain, device embedded in tissue or plaque and muscular rigidity. 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 117,271 reports carrying product code LKK. 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 15 | 6.1% | 8.1% |
| Breakthe device broke | 13 | 5.3% | 0.5% |
| Malposition of device | 12 | 4.9% | 0.3% |
| Insufficient device problem information | 10 | 4.1% | 7% |
| Detachment of device component | 7 | 2.9% | 0.1% |
| Difficult to removethe device was hard to remove | 5 | 2% | 0% |
| Improper or incorrect procedure or method | 5 | 2% | 4% |
| Migration or expulsion of device | 5 | 2% | 5.7% |
| Aspiration issue | 4 | 1.6% | 2.8% |
| Obstruction of flow | 4 | 1.6% | 2.8% |
| Physical resistance | 4 | 1.6% | 0% |
| Fluid/blood leak | 3 | 1.2% | 2.1% |
| Leak/splashthe device leaked | 3 | 1.2% | 0.5% |
| Stretched | 3 | 1.2% | 0% |
| Disconnection | 2 | 0.8% | 1.4% |
| Fracturea broken bone | 2 | 0.8% | 0.5% |
| Insufficient flow or under infusion | 2 | 0.8% | 6.7% |
| Kinkedthe tube or line kinked | 2 | 0.8% | 1.5% |
| Material separation | 2 | 0.8% | 0% |
| Replace | 2 | 0.8% | 3.5% |
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 |
|---|---|---|
| Painpain, site not specified | 13 | 5.3% |
| Device embedded in tissue or plaque | 11 | 4.5% |
| Muscular rigidity | 5 | 2% |
| Abdominal painstomach or belly pain | 4 | 1.6% |
| Complaint, ill-defined | 4 | 1.6% |
| Failure of implant | 4 | 1.6% |
| Peritonitis | 4 | 1.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 1.2% |
| Bacterial infectiona bacterial infection | 3 | 1.2% |
| Hemorrhage/blood loss/bleeding | 3 | 1.2% |
| Air embolism | 2 | 0.8% |
| Fever | 2 | 0.8% |
| Hypersensitivity/allergic reaction | 2 | 0.8% |
| Pericardial effusionfluid around the heart | 2 | 0.8% |
| Therapeutic response, decreased | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Catheter | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 244 | 117,271 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 37 | 14 | 9 |
| Classified as injury | 60.7% | 64% | 36.2% |
| Classified as malfunction | 27.9% | 32.6% | 62.3% |
| Filed by the manufacturer | 47.5% | 99.1% | 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 LKK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Synchromed El | 7,189 | 2 | 4.9% |
| Synchromed | 3,429 | 3 | 3.2% |
| Indura | 2,730 | 0 | 0.8% |
| Intrathecal Catheter | 696 | 18 | 0.1% |
| Implantable Drug Infusion Pump | 649 | 177 | 0.9% |
| Ascenda | 570 | 14 | 0.9% |
| Infusion Pump | 830 | 6 | 3.7% |
| Indura Catheter | 373 | 0 | 0% |
| Prometra Programmable Pump | 348 | 0 | 6.6% |
| Intera 3000 | 307 | 99 | 0% |
| Isomed | 281 | 1 | 2.5% |
| Unknown Implantable Pump | 233 | 0 | 2.6% |
| N'vision | 269 | 0 | 0.7% |
| Implantable Infusion Pump | 211 | 0 | 3.8% |
| Unknown Infusion Pump | 157 | 0 | 1.9% |
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 Catheter reports
How many FDA reports name Catheter?
244 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (60.7%), malfunction (27.9%) and other (6.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (6.1%), break (5.3%), malposition of device (4.9%), insufficient device problem information (4.1%) and detachment of device component (2.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (47.5%), voluntary reports (38.5%) and distributor reports (1.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Catheter 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.