Devices › Tubes, gastrointestinal (and accessories)
Device brand name · Knt
Corflo Cubby Low Profile Gastrostomy Device: medical device reports filed with FDA
440 reports name it, 2008–2009. Manufacturer given most often on reports: Boston Scientific. Product code KNT.
- 440
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.1%
- classified as malfunction
- 47% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 440 reports that name the brand "Corflo Cubby Low Profile Gastrostomy Device" (knt), received between June 2008 and August 2009; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (99.1%) and injury (0.9%); across all tubes, gastrointestinal (and accessories) reports (product code KNT) death is recorded in 2.4% and malfunction in 47%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device damaged prior to use (29.1%), balloon rupture (16.4%) and locking mechanism failure (13%). The patient problems coded most often are therapy/non-surgical treatment, additional. 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
No report naming Corflo Cubby Low Profile Gastrostomy Device was received in the five years to August 2026; the latest was received in August 2009.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,205 reports carrying product code KNT. 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 damaged prior to usethe device was damaged before use | 128 | 29.1% | 0.6% |
| Balloon rupture | 72 | 16.4% | 0.9% |
| Locking mechanism failure | 57 | 13% | 0.4% |
| Leak/splashthe device leaked | 49 | 11.1% | 4.7% |
| Crackthe device cracked | 48 | 10.9% | 1% |
| Detachment of device component | 26 | 5.9% | 4.6% |
| Component(s), broken | 15 | 3.4% | 0.8% |
| Balloon leak(s) | 11 | 2.5% | 0.2% |
| Deflation problem | 10 | 2.3% | 2% |
| Deflation, cause unknown | 9 | 2% | 0.3% |
| Inflation problem | 7 | 1.6% | 1.3% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 1.4% | 0.4% |
| Breakthe device broke | 4 | 0.9% | 7.5% |
| Dislodged | 3 | 0.7% | 0.2% |
| Balloon asymmetrical | 2 | 0.5% | 0% |
| Balloon pinhole | 2 | 0.5% | 0% |
| Fluid/blood leak | 2 | 0.5% | 4.5% |
| Loose | 2 | 0.5% | 0.2% |
| Loose or intermittent connection | 2 | 0.5% | 0.3% |
| Balloon burst | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 7 | 1.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Corflo Cubby Low Profile Gastrostomy Device | Product code KNT | All MAUDE reports |
|---|---|---|---|
| Reports | 440 | 26,205 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 24 | 9 |
| Classified as injury | 0.9% | 49% | 36.2% |
| Classified as malfunction | 99.1% | 47% | 62.3% |
| Filed by the manufacturer | 100% | 91% | 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 KNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Duodopa Duopa | 5,925 | 484 | 2% |
| Abbvie Peg | 1,633 | 0 | 1.7% |
| Bard DigniShield Stool Management System | 750 | 94 | 0.7% |
| Kangaroo | 4,328 | 117 | 0.2% |
| EndoVive Safety PEG Kit | 650 | 23 | 0.8% |
| EndoVive Standard PEG Kit | 534 | 15 | 2.1% |
| Tube Gastrointestinal And Access | 448 | 0 | 1.1% |
| Endovive Jejunal Feeding Tube | 422 | 0 | 0.2% |
| Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | 333 | 0 | 0.9% |
| Endovive Securi-T | 264 | 0 | 0.4% |
| Abbvie J | 263 | 0 | 6.8% |
| Endovive Two-Port Ttp Jejunal Feeding Tube Cap | 262 | 0 | 1.5% |
| CORTRAK 2 Enteral Access System | 190 | 37 | 14.7% |
| Flexi-Seal Fms | 195 | 0 | 1.5% |
| Replacement Tube | 183 | 0 | 0.5% |
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 Corflo Cubby Low Profile Gastrostomy Device reports
How many FDA reports name Corflo Cubby Low Profile Gastrostomy Device?
440 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.1%) and injury (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device damaged prior to use (29.1%), balloon rupture (16.4%), locking mechanism failure (13%), leak/splash (11.1%) and crack (10.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Corflo Cubby Low Profile Gastrostomy Device 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.