Device brand name · Snare flexible
Captivator: medical device reports filed with FDA
510 reports name it, 2002–2026. Manufacturer given most often on reports: Boston Scientific. Product code FDI.
- 510
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 29
- reports, 12 months to August 2026
- 32 in the 12 months before
- 90.6%
- classified as malfunction
- 86.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
510 medical device reports received by FDA name the brand "Captivator" (snare flexible); the manufacturer given most often on reports is Boston Scientific; received from March 2002 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
29 reports arrived in the 12 months to August 2026, close to the 32 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 malfunction (90.6%) and injury (9.4%); across all snare, flexible reports (product code FDI) death is recorded in 0.2% and malfunction in 86.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to cut (46.7%), failure to deliver energy (18.2%) and detachment of device component (12.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, burn(s) and no patient involvement. 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 4,658 reports carrying product code FDI. 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 |
|---|---|---|---|
| Failure to cut | 238 | 46.7% | 24.5% |
| Failure to deliver energy | 93 | 18.2% | 10.8% |
| Detachment of device component | 65 | 12.7% | 13.7% |
| Breakthe device broke | 59 | 11.6% | 15.3% |
| Entrapment of device | 34 | 6.7% | 4.6% |
| Detachment of device or device componentpart of the device came off | 26 | 5.1% | 3.4% |
| Electrical /electronic property probleman electrical or electronic problem | 21 | 4.1% | 2.4% |
| Retraction problem | 21 | 4.1% | 3.9% |
| Mechanical problema mechanical problem | 19 | 3.7% | 1.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 15 | 2.9% | 1.2% |
| Material twisted/bent | 13 | 2.5% | 1.5% |
| Device contamination with chemical or other material | 12 | 2.4% | 1.4% |
| Difficult to open or close | 12 | 2.4% | 2.3% |
| Device-device incompatibility | 9 | 1.8% | 1% |
| Defective devicethe device was defective | 5 | 1% | 1% |
| Material split, cut or torn | 5 | 1% | 0.4% |
| Positioning problem | 4 | 0.8% | 1.9% |
| Human-device interface problem | 3 | 0.6% | 0.3% |
| Nonstandard device | 2 | 0.4% | 0.2% |
| Overheating of device | 2 | 0.4% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 18 | 3.5% |
| Burn(s)a burn | 4 | 0.8% |
| No patient involvement | 4 | 0.8% |
| Tissue damage | 4 | 0.8% |
| Bowel perforation | 3 | 0.6% |
| Electric shockan electric shock | 3 | 0.6% |
| Perforation | 3 | 0.6% |
| Abdominal painstomach or belly pain | 2 | 0.4% |
| Device embedded in tissue or plaque | 2 | 0.4% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.4% |
| Blood loss | 1 | 0.2% |
| Painpain, site not specified | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Captivator | Product code FDI | All MAUDE reports |
|---|---|---|---|
| Reports | 510 | 4,658 | 26,136,888 |
| Share of that pool | — | 10.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 9.4% | 12.8% | 36.2% |
| Classified as malfunction | 90.6% | 86.4% | 62.3% |
| Filed by the manufacturer | 98.4% | 95% | 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 FDI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| SENSATION Short Throw | 733 | 83 | 0% |
| Rotatable Snare | 486 | 20 | 0% |
| Captiflex | 400 | 13 | 0% |
| Ultratome XL | 411 | 38 | 0.5% |
| ACUSNARE Polypectomy Snare | 319 | 13 | 0% |
| Hydratome Rx Sphincterotome | 458 | 0 | 0.2% |
| Boston Scientific | 580 | 5 | 3.3% |
| Fresenius | 314 | 0 | 6.1% |
| NCircle Tipless Stone Extractor | 1,463 | 232 | 0% |
| Prisma Control Unit | 566 | 0 | 6% |
| Conmed | 900 | 89 | 0.2% |
| Optiflux 180nre Dialyzer Finished Assy | 3,373 | 69 | 0.6% |
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 Captivator reports
How many FDA reports name Captivator?
510 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 29 in the latest 12 months.
What kinds of events are reported?
malfunction (90.6%) and injury (9.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to cut (46.7%), failure to deliver energy (18.2%), detachment of device component (12.7%), break (11.6%) and entrapment of device (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.4%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Captivator 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.