Device manufacturer, as written on reports
Lake Region Medical: medical device reports filed with FDA
1,953 reports name it as the manufacturer of the device involved, 2008–2026.
- 1,953
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 311
- reports, 12 months to August 2026
- 250 in the 12 months before
- 68.8%
- classified as malfunction
- 62.3% across all reports
- 5.1%
- classified as death, as reported
- 0.9% across all reports
1,953 medical device reports received by FDA give Lake Region Medical as the manufacturer of the device involved, 0% of the MAUDE database, from February 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
311 reports arrived in the 12 months to August 2026, up 24% from 250 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 (68.8%), injury (26.1%) and death (5.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Starter guidewire | Wire, guide, catheter | 340 | 179 | 1.2% |
| Zipwire Hydrophilic Guidewire | Wire, guide, catheter | 263 | 0 | 0% |
| Preform Guidewire - Safari2 | Wire, guide, catheter | 190 | 0 | 13.2% |
| Thruway Guidewire | Wire, guide, catheter | 159 | 0 | 0.6% |
| Enroute St Mod S Hy Us 95-014 | Wire, guide, catheter | 86 | 13 | 1.6% |
| Zipwire Hydrophilic Guide Wire | Wire, guide, catheter | 5 | 0 | 3.6% |
| Achieve Advance Mapping Catheter | Catheter, electrode recording, or probe, electrode recording | 1 | 34 | 4.4% |
| Boston Scientific | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | 1 | 5 | 3.3% |
| Guidewire | Wire, guide, catheter | 1 | 15 | 0.6% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| DQX | Wire, guide, catheter | 1,682 | 86.1% |
| EZB | Stylet for catheter, gastro-urology | 103 | 5.3% |
| HIH | Hysteroscope (and accessories) | 13 | 0.7% |
| OCY | Endoscopic guidewire, gastroenterology-urology | 13 | 0.7% |
| FCL | Forceps, biopsy, non-electric | 3 | 0.2% |
| GEN | Forceps, general & plastic surgery | 3 | 0.2% |
| DRF | Catheter, electrode recording, or probe, electrode recording | 1 | 0.1% |
| GCJ | Laparoscope, general & plastic surgery | 1 | 0.1% |
| KNT | Tubes, gastrointestinal (and accessories) | 1 | 0.1% |
| KNY | Accessories, catheter, g-u | 1 | 0.1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Lake Region Medical reports
How many FDA device reports name Lake Region Medical as manufacturer?
1,953 reports through August 2026, 311 of them in the latest 12 months.
Which of its brands appear most often?
Starter guidewire (340), Zipwire Hydrophilic Guidewire (263), Preform Guidewire - Safari2 (190), Thruway Guidewire (159) and Enroute St Mod S Hy Us 95-014 (86).
Which device types does it report on?
wire, guide, catheter (86.1%), stylet for catheter, gastro-urology (5.3%), hysteroscope (and accessories) (0.7%) and endoscopic guidewire, gastroenterology-urology (0.7%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.