Device manufacturer, as written on reports
Invacare: medical device reports filed with FDA
2,308 reports name it as the manufacturer of the device involved, 1992–2025.
- 2,308
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 2
- reports, 12 months to August 2026
- 14 in the 12 months before
- 35.4%
- classified as malfunction
- 62.3% across all reports
- 9.7%
- classified as death, as reported
- 0.9% across all reports
2,308 medical device reports received by FDA give Invacare as the manufacturer of the device involved, 0% of the MAUDE database, from March 1992 to November 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
2 reports arrived in the 12 months to August 2026, down 86% from 14 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 injury (43.4%), malfunction (35.4%) and death (9.7%). 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 |
|---|---|---|---|---|
| Powered Wheelchair | Wheelchair, powered | 431 | 0 | 0.1% |
| Invacare | Wheelchair, mechanical | 161 | 0 | 17% |
| Portable Oxygen Generator Concentrator Homefill | Generator, oxygen, portable | 112 | 0 | 0.2% |
| Mechanical Manual Wheelchair | Wheelchair, mechanical | 72 | 0 | 0% |
| Mechanical Walker Rollator | Walker, mechanical | 54 | 0 | 0% |
| Ac-Powered Patient Lift | Lift, patient, ac-powered | 46 | 0 | 3.2% |
| Ac-Powered Adjustable Hospital Bed Including Rails | Bed, ac-powered adjustable hospital | 43 | 0 | 1.3% |
| Invacare Power Wheelchair | Wheelchair, powered | 35 | 0 | 5.2% |
| Perfecto2 V With Sensor 9153650799 | Generator, oxygen, portable | 27 | 0 | 0% |
| Non Ac-Powered Patient Lift | Lift, patient, non-ac-powered | 19 | 0 | 0.3% |
| Power Chair 20 Wide By 18 Deep For Pmi | Wheelchair, powered | 14 | 0 | 0% |
| Perfecto2 Oxygen Concentrator With Senso2 9153646963 | Generator, oxygen, portable | 9 | 0 | 0% |
| Mechanical Chair/Transport Chair | Chair, with casters | 8 | 0 | 0.2% |
| Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box | Wheelchair, powered | 8 | 0 | 0.2% |
| Transport 20 In X 16 In 9153637574 | Wheelchair, mechanical | 7 | 0 | 0.1% |
| Daily Activity Assist Devices | Aid, transfer | 4 | 0 | 0% |
| Hoyer Lift | Lift, patient, non-ac-powered | 4 | 0 | 2.7% |
| 9xt Swingaway Frame Style 9153629153 | Wheelchair, mechanical | 3 | 0 | 0% |
| Immersion Hydrobath | Bath, hydro-massage | 3 | 0 | 0% |
| M51p Blue Base W/Mk5 Nx Spj+ 9153642087 | Wheelchair, powered | 3 | 0 | 0% |
| Perfecto2 Oxygen Concentrator 9153646962 | Generator, oxygen, portable | 3 | 0 | 0.1% |
| Portable Air Compressor For Medical Purposes | Compressor, air, portable | 3 | 0 | 0% |
| Rollator 9153651315 | Walker, mechanical | 3 | 0 | 0% |
| Arrow | System, balloon, intra-aortic and control | 2 | 65 | 3.4% |
| Tdxsp Wet Black Euro Narrow Base W/ 23-1 Ssd Gear Box | Wheelchair, powered | 2 | 0 | 0% |
| Tracer Transport Chair 19 X 16 9153647029 | Wheelchair, mechanical | 2 | 0 | 0% |
| Cs3 Bed 9153651161 | Bed, ac-powered adjustable hospital | 1 | 0 | 0% |
| Full Electric Foot Spring 9153638201 | Bed, ac-powered adjustable hospital | 1 | 0 | 0.4% |
| Insignia | Pulse generator, permanent, implantable | 1 | 0 | 1.3% |
| Motorized 3-Wheeled Vehicle For Outside Transport | Vehicle, motorized 3-wheeled | 1 | 0 | 0.1% |
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 |
|---|---|---|---|
| ITI | Wheelchair, powered | 695 | 30.1% |
| IOR | Wheelchair, mechanical | 338 | 14.6% |
| CAW | Generator, oxygen, portable | 281 | 12.2% |
| FNL | Bed, ac-powered adjustable hospital | 221 | 9.6% |
| FSA | Lift, patient, non-ac-powered | 214 | 9.3% |
| FNG | Lift, patient, ac-powered | 122 | 5.3% |
| ITJ | Walker, mechanical | 116 | 5% |
| FNJ | Bed, manual | 49 | 2.1% |
| FNM | Mattress, air flotation, alternating pressure | 28 | 1.2% |
| INM | Chair, with casters | 28 | 1.2% |
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 Invacare reports
How many FDA device reports name Invacare as manufacturer?
2,308 reports through August 2026, 2 of them in the latest 12 months.
Which of its brands appear most often?
Powered Wheelchair (431), Invacare (161), Portable Oxygen Generator Concentrator Homefill (112), Mechanical Manual Wheelchair (72) and Mechanical Walker Rollator (54).
Which device types does it report on?
wheelchair, powered (30.1%), wheelchair, mechanical (14.6%), generator, oxygen, portable (12.2%) and bed, ac-powered adjustable hospital (9.6%).
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.