Tube tracheostomy and tube cuff: medical device reports filed with FDA

15,022 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.

15,022
reports with this product code: 0.1% of all MAUDE reports; 908
reports, 12 months to August 2026: 1,087 in the 12 months before; 63.9%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

Product code JOH is FDA's classification for "Tube tracheostomy and tube cuff" (anesthesiology panel), a class 2 device. 15,022 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.

908 reports arrived in the 12 months to August 2026, down 16% from 1,087 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 (63.9%), injury (34.6%) and death (1.1%). 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
Shiley	5,668	1,513	1.1%	74.5%
Bivona	669	11	1%	73.7%
Shiley Disposable Cannula Low Pressure	400	0	0.8%	4%
Shiley Low Pressure Cuffed	369	0	0.4%	12.6%
Bivona Customized Tracheostomy Tubes	199	24	1%	80.5%
Bivona Flextend Pediatric and Neonatal Trach Tube	180	44	0%	81.7%
Bivona Tracheostomy Tube Neonatal/Pediatric	167	7	0.9%	77.2%
Shiley Fenestrated Low Pressure Cuffed	152	0	0%	6.1%
Portex	149	8	0.6%	80.6%
Portex Blue Line Ultra Tracheostomy Tube	116	30	0%	69.7%
Mallinckrodt	60	1	1.2%	57.3%
Portex Endotracheal Tube	8	25	0%	75.8%
Kangaroo Joey Pump W/Pole Clmp	2	0	0.4%	98.4%
Scd 700 Compression System-Us	2	0	0%	100%
Flextend	1	203	0.7%	18.4%
Level 1 Hotline Low Flow System Hl-90	1	0	0%	100%
Pneupac	1	0	0%	97.1%
TaperGuard	1	124	0.4%	86.4%

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
Smiths Medical Asd	4,615	30.7%
Mmj De Cv Usd	2,494	16.6%
Mallinckrodt Medical	1,194	7.9%
Covidien	884	5.9%
Covidien/Formerly Tyco Healthcare	761	5.1%
Covidien Juarez Mmj	740	4.9%
Smiths Medical International	549	3.7%
Covidien Formerly Tyco Healthcare	378	2.5%
Smiths Healthcare Manufacturing De C V	344	2.3%
Smiths Medical	224	1.5%
Icu Medical	163	1.1%
Icu Medical Healthcare Manufacturing De C V	125	0.8%
Unomedical Sdn Bhd	119	0.8%
St Paul	56	0.4%
Smith S Medical Asd	15	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 and report source

Event type

Death1.1%164

Injury34.6%5,201

Malfunction63.9%9,605

Other0.2%25

Not given0.2%27

Who filed

Manufacturer report95.5%14,342

Voluntary report1.8%277

User facility report0%0

Distributor report0.9%138

Not given1.8%265

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

Device problems coded

Device problem (FDA code)	Reports	Share
Inflation problem	1,867	12.4%
Air leak	1,716	11.4%
Gas/air leak	1,558	10.4%
Leak/splashthe device leaked	1,193	7.9%
Breakthe device broke	766	5.1%
Material split, cut or torn	615	4.1%
Defective component	513	3.4%
Fluid/blood leak	429	2.9%
Disconnection	368	2.4%
Connection problema connection problem	316	2.1%
Crackthe device cracked	288	1.9%
Material separation	258	1.7%
Deflation problem	241	1.6%
Device operates differently than expectedthe device behaved unexpectedly	223	1.5%
Detachment of device component	221	1.5%
Fracturea broken bone	199	1.3%
Defective devicethe device was defective	184	1.2%
Inadequacy of device shape and/or size	173	1.2%
Replace	170	1.1%
Material integrity problema problem with the device material	167	1.1%

Questions about tube tracheostomy and tube cuff reports

What is product code JOH?

FDA's classification code for "Tube tracheostomy and tube cuff", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

15,022 reports through August 2026, 908 of them in the latest 12 months.

Which brands appear most often?

Shiley (5,668), Bivona (669), Shiley Disposable Cannula Low Pressure (400), Shiley Low Pressure Cuffed (369) and Bivona Customized Tracheostomy Tubes (199). 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.