Device brand name · Snare flexible

Captiflex: medical device reports filed with FDA

400 reports name it, 2011–2026. Manufacturer given most often on reports: Boston Scientific - Costa Rica Coyol. Product code FDI.

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.

400
device reports naming the brand: 0% of all MAUDE reports · about 27 a year; 13
reports, 12 months to August 2026: 9 in the 12 months before; 94.3%
classified as malfunction: 86.4% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 400 reports that name the brand "Captiflex" (snare flexible), received between September 2011 and July 2026; the manufacturer given most often on reports is Boston Scientific - Costa Rica Coyol. Spellings of one product vary from report to report.

13 reports arrived in the 12 months to August 2026, up 44% from 9 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 (94.3%) and injury (5.8%); 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 (34%), detachment of device component (21.3%) and failure to deliver energy (12.3%). The patient problems coded most often are hemorrhage/blood loss/bleeding, tissue damage and perforation. 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

Death0%0

Injury5.8%23

Malfunction94.3%377

Other0%0

Not given0%0

Who filed the report

Manufacturer report97.3%389

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given2.8%11

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	136	34%	24.5%
Detachment of device component	85	21.3%	13.7%
Failure to deliver energy	49	12.3%	10.8%
Breakthe device broke	48	12%	15.3%
Entrapment of device	36	9%	4.6%
Retraction problem	19	4.8%	3.9%
Unsealed device packaging	15	3.8%	3.6%
Electrical /electronic property probleman electrical or electronic problem	14	3.5%	2.4%
Device operates differently than expectedthe device behaved unexpectedly	11	2.8%	1.2%
Defective devicethe device was defective	9	2.3%	1%
Difficult to open or close	8	2%	2.3%
Human-device interface problem	7	1.8%	0.3%
Material twisted/bent	4	1%	1.5%
Mechanical problema mechanical problem	4	1%	1.5%
Detachment of device or device componentpart of the device came off	3	0.8%	3.4%
Device markings/labelling problema problem with the device markings or label	3	0.8%	0.1%
Material deformation	3	0.8%	1.4%
Device contamination with chemical or other material	2	0.5%	1.4%
Material frayed	2	0.5%	0.2%
Sparking	2	0.5%	0.4%

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	12	3%
Tissue damage	6	1.5%
Perforation	4	1%
Blood loss	1	0.3%
Burn(s)a burn	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Captiflex	Product code FDI	All MAUDE reports
Reports	400	4,658	26,136,888
Share of that pool	—	8.6%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	5.8%	12.8%	36.2%
Classified as malfunction	94.3%	86.4%	62.3%
Filed by the manufacturer	97.3%	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%
Captivator	510	29	0%
Rotatable Snare	486	20	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 Captiflex reports

How many FDA reports name Captiflex?

400 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.

What kinds of events are reported?

malfunction (94.3%) and injury (5.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to cut (34%), detachment of device component (21.3%), failure to deliver energy (12.3%), break (12%) and entrapment of device (9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (97.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Captiflex 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.