Catheter, hemodialysis, non-implanted: medical device reports filed with FDA

3,212 reports carry this product code, 1995–2026; 11 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.

3,212
reports with this product code: 0% of all MAUDE reports; 151
reports, 12 months to August 2026: 191 in the 12 months before; 75.8%
classified as malfunction: 62.3% across all reports; 2.3%
classified as death, as reported: 0.9% across all reports

Product code MPB is FDA's classification for "Catheter, hemodialysis, non-implanted" (gastroenterology, Urology panel), a class 2 device. 3,212 medical device reports carry this product code, 0% of the MAUDE database, from March 1995 to August 2026.

151 reports arrived in the 12 months to August 2026, down 21% from 191 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 (75.8%), injury (18.9%) and death (2.3%). 11 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
Mahurkar	439	6	1.1%	92.4%
Arrow Hemodialysis Set 2-Lumen 12 Fr X 20 Cm	106	68	0.2%	98.5%
Arrow Hemodialysis Set 2-Lumen 12 Fr X 16 Cm	86	26	1%	98.5%
Mahurkar Elite	80	10	3.3%	82.2%
Ash Split Catheter	70	0	3.5%	12.8%
Dialysis Unknown	26	6	5%	63.7%
Kendall	8	23	2.3%	61.5%
Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm	2	12	0%	98.2%
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm	1	170	0.1%	98.4%
Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb	1	63	1%	95.1%
Liberty Select Cycler	1	0	4.8%	67.6%

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
Covidien Mfg Solutions	407	12.7%
Covidien	404	12.6%
Medcomp	359	11.2%
Arrow International	335	10.4%
Bard Access Systems	262	8.2%
C R Bard Basd	61	1.9%
Gambro Dialysatoren	29	0.9%
C R Bard Basd -3006260740	17	0.5%
Arrow Intl	13	0.4%
Vantive US Healthcare	4	0.1%
Teleflex	3	0.1%
Bard	2	0.1%
Angiodynamics	1	0%
Fresenius USA	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

Death2.3%73

Injury18.9%606

Malfunction75.8%2,436

Other2.1%69

Not given0.9%28

Who filed

Manufacturer report93.8%3,012

Voluntary report2.4%78

User facility report0%0

Distributor report0.4%12

Not given3.4%110

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

Device problems coded

Device problem (FDA code)	Reports	Share
Crackthe device cracked	502	15.6%
Leak/splashthe device leaked	304	9.5%
Breakthe device broke	227	7.1%
Explanted	215	6.7%
Material puncture/hole	191	5.9%
Fluid/blood leak	167	5.2%
Material deformation	150	4.7%
Replace	136	4.2%
Difficult to removethe device was hard to remove	131	4.1%
Unraveled material	122	3.8%
Hole in material	110	3.4%
Material frayed	101	3.1%
Implant, removal of	96	3%
Material separation	94	2.9%
Material twisted/bent	88	2.7%
Product quality problem	84	2.6%
Kinkedthe tube or line kinked	75	2.3%
Repair	70	2.2%
Deformation due to compressive stress	68	2.1%
Component(s), broken	65	2%

Questions about catheter, hemodialysis, non-implanted reports

What is product code MPB?

FDA's classification code for "Catheter, hemodialysis, non-implanted", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,212 reports through August 2026, 151 of them in the latest 12 months.

Which brands appear most often?

Mahurkar (439), Arrow Hemodialysis Set 2-Lumen 12 Fr X 20 Cm (106), Arrow Hemodialysis Set 2-Lumen 12 Fr X 16 Cm (86), Mahurkar Elite (80) and Ash Split Catheter (70). 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.