Walker, mechanical: medical device reports filed with FDA

15,177 reports carry this product code, 1992–2026; 18 brands with a page.

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.

15,177
reports with this product code: 0.1% of all MAUDE reports; 5,566
reports, 12 months to August 2026: 94 in the 12 months before; 54.4%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code ITJ is FDA's classification for "Walker, mechanical" (physical Medicine panel), a class 1 device. 15,177 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.

5,566 reports arrived in the 12 months to August 2026, up 5821% from 94 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 (54.4%), injury (10.5%) and other (1.7%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Mechanical Walker Rollator	5,607	0	0%	10.5%
Medline	5,199	26,184	0.1%	97.9%
Rollator 9153651315	741	0	0%	98.5%
Drive	313	20	4.4%	13.1%
Guardian	164	350	0.4%	72.2%
Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547	156	0	0%	96.4%
Drive Medical	118	0	10%	5.2%
Mechanical Manual Wheelchair	60	0	0%	82.3%
Transport 20 In X 16 In 9153637574	15	0	0.1%	99.1%
Daily Activity Assist Devices	6	0	0%	36.9%
Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back	6	0	0%	100%
Invacare	3	0	17%	27%
Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 9153649403	3	0	0%	98.9%
Powered Wheelchair	2	0	0.1%	96.8%
Donjoy	1	3	0%	68.9%
Invacare Power Wheelchair	1	0	5.2%	16.1%
Mustang	1	491	0.3%	94.1%
T4/Wd28/Hd/Adult/18/Bh16/At903/U2222c/U67 9153653569	1	0	0%	99.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medline Industries	5,713	37.6%
Genteel Homecare Products	1,099	7.2%
Danyang Maxthai Medical Equipment	972	6.4%
Kenstone Metal	800	5.3%
Invacare Taylor Street	241	1.6%
Invacare	116	0.8%
Invamex	61	0.4%
Invacare Suzhou	9	0.1%
Arjo Hospital Equipment	6	0%
Invacare Rehabilitation Equipment	3	0%
Invacare Rehabilitation Equip	2	0%
Arjohuntleigh Polska Sp Z O O	1	0%

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 and report source

Event type

Death0.3%40

Injury10.5%1,590

Malfunction54.4%8,258

Other1.7%253

Not given33.2%5,036

Who filed

Manufacturer report87.5%13,280

Voluntary report1.5%228

User facility report0%0

Distributor report10.4%1,579

Not given0.6%90

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	3,437	22.6%
Unstable	2,018	13.3%
Fracturea broken bone	1,830	12.1%
Material twisted/bent	1,019	6.7%
Product quality problem	729	4.8%
Crackthe device cracked	644	4.2%
Activation problem	639	4.2%
Detachment of device component	630	4.2%
Loose or intermittent connection	537	3.5%
Device slipped	478	3.1%
Bent	442	2.9%
Mechanical problema mechanical problem	435	2.9%
Device operates differently than expectedthe device behaved unexpectedly	341	2.2%
Detachment of device or device componentpart of the device came off	331	2.2%
Damaged thread	232	1.5%
Mechanical jam	218	1.4%
Collapse	214	1.4%
Unintended movement	174	1.1%
Insufficient device problem information	173	1.1%
Naturally worn	169	1.1%

Questions about walker, mechanical reports

What is product code ITJ?

FDA's classification code for "Walker, mechanical", class 1, reviewed by the physical Medicine panel. Every device report carries the product code of the device involved.

How many reports carry this code?

15,177 reports through August 2026, 5,566 of them in the latest 12 months.

Which brands appear most often?

Mechanical Walker Rollator (5,607), Medline (5,199), Rollator 9153651315 (741), Drive (313) and Guardian (164). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.