Devices › Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Device brand name · Convenience kit
Boston Scientific: medical device reports filed with FDA
580 reports name it, 1999–2026. Manufacturer given most often on reports: Boston Scientific. Product code DTL.
- 580
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 5
- reports, 12 months to August 2026
- 3 in the 12 months before
- 55%
- classified as malfunction
- 90.7% across the product code
- 3.3%
- classified as death, as reported
- 19 reports · not verified by FDA
580 medical device reports received by FDA name the brand "Boston Scientific" (convenience kit); the manufacturer given most often on reports is Boston Scientific; received from May 1999 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
5 reports arrived in the 12 months to August 2026, up 67% from 3 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 (55%), injury (37.9%) and death (3.3%); across all adaptor, stopcock, manifold, fitting, cardiopulmonary bypass reports (product code DTL) death is recorded in 0.8% and malfunction in 90.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are bubble(s) (13.3%), replace (12.2%) and break (8.6%). The patient problems coded most often are hospitalization required, therapy/non-surgical treatment, additional and foreign body, removal of. 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 2,159 reports carrying product code DTL. 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 |
|---|---|---|---|
| Bubble(s) | 77 | 13.3% | 1.9% |
| Replace | 71 | 12.2% | 1% |
| Breakthe device broke | 50 | 8.6% | 12.3% |
| Air leak | 44 | 7.6% | 5.4% |
| Difficult to removethe device was hard to remove | 38 | 6.6% | 0.6% |
| Detachment of device component | 27 | 4.7% | 2.7% |
| Device, removal of (non-implant) | 27 | 4.7% | 0.1% |
| Unsealed device packaging | 22 | 3.8% | 0.7% |
| Sterility | 19 | 3.3% | 0.6% |
| Sticking | 19 | 3.3% | 0% |
| Device, or device fragments remain in patient | 16 | 2.8% | 0% |
| Leak/splashthe device leaked | 15 | 2.6% | 33.3% |
| Air eliminator, defective | 11 | 1.9% | 0.3% |
| Balloon rupture | 11 | 1.9% | 0% |
| Material separation | 11 | 1.9% | 0.5% |
| Failure to advance | 10 | 1.7% | 0% |
| Insufficient device problem information | 10 | 1.7% | 0.1% |
| Migration or expulsion of device | 10 | 1.7% | 0% |
| Crackthe device cracked | 9 | 1.6% | 2.3% |
| Defective devicethe device was defective | 9 | 1.6% | 1.1% |
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 |
|---|---|---|
| Hospitalization required | 27 | 4.7% |
| Therapy/non-surgical treatment, additional | 26 | 4.5% |
| Foreign body, removal of | 24 | 4.1% |
| Deaththe patient died; cause not stated by this term | 20 | 3.4% |
| No patient involvement | 18 | 3.1% |
| Nonresorbable materials, unretrieved in body | 14 | 2.4% |
| Chest painchest pain | 13 | 2.2% |
| Surgical procedure, additional | 13 | 2.2% |
| Surgical procedure | 12 | 2.1% |
| Device embedded in tissue or plaque | 11 | 1.9% |
| Painpain, site not specified | 11 | 1.9% |
| Burn(s)a burn | 7 | 1.2% |
| Occlusion | 7 | 1.2% |
| Air embolism | 5 | 0.9% |
| Erosion | 5 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Boston Scientific | Product code DTL | All MAUDE reports |
|---|---|---|---|
| Reports | 580 | 2,159 | 26,136,888 |
| Share of that pool | — | 26.9% | 0% |
| Classified as death, per 1,000 reports | 33 | 8 | 9 |
| Classified as injury | 37.9% | 6.8% | 36.2% |
| Classified as malfunction | 55% | 90.7% | 62.3% |
| Filed by the manufacturer | 42.4% | 95.7% | 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 DTL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Copilot | 226 | 26 | 0% |
| Copilot Bleedback Control Valve | 215 | 0 | 0% |
| Merit Custom Kit | 1,590 | 13 | 0.1% |
| Navilyst Medical | 252 | 0 | 0.4% |
| Indeflator | 356 | 23 | 0% |
| AngioDynamics | 174 | 14 | 1.7% |
| Custom Tubing Pack | 1,039 | 353 | 1.1% |
| Deroyal | 587 | 14 | 0.7% |
| Attain | 459 | 0 | 1.5% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Acist | 348 | 14 | 10.6% |
| Bulk Non Ster Xcoat Delph Pump | 266 | 0 | 0.4% |
| Hlm Tubing Set W/Bioline Coating | 439 | 0 | 7.1% |
| Medex | 202 | 8 | 0% |
| Stopcock | 164 | 16 | 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 Boston Scientific reports
How many FDA reports name Boston Scientific?
580 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
malfunction (55%), injury (37.9%) and death (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
bubble(s) (13.3%), replace (12.2%), break (8.6%), air leak (7.6%) and difficult to remove (6.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (42.4%), voluntary reports (41.9%) and distributor 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 Boston Scientific 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.