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

11,458 reports carry this product code, 1994–2026; 21 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.

11,458
reports with this product code: 0% of all MAUDE reports; 824
reports, 12 months to August 2026: 1,207 in the 12 months before; 75.8%
classified as malfunction: 62.3% across all reports; 2.6%
classified as death, as reported: 0.9% across all reports

Product code MSD is FDA's classification for "Catheter, hemodialysis, implanted" (gastroenterology, Urology panel), a class 2 device. 11,458 medical device reports carry this product code, 0% of the MAUDE database, from August 1994 to August 2026.

824 reports arrived in the 12 months to August 2026, down 32% from 1,207 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 (20%) and death (2.6%). 21 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
Palindrome	1,402	52	1.3%	88.1%
GlidePath	774	225	0.9%	89.3%
HemoStar	360	84	0.8%	86.1%
Lifesite Hemodialysis Access System	342	0	6.4%	9.1%
Equistream Split Tip	295	125	0%	85.8%
Arrow Hemodialysis Kit 2-L 15 Fr X 19 Cm	258	40	0.4%	97.8%
HemoSplit Catheter	247	49	1.6%	76.7%
Ash Split Catheter	172	0	3.5%	12.8%
Dialysis Unknown	94	6	5%	63.7%
Mahurkar	91	6	1.1%	92.4%
Angiodynamics / Bioflo	27	0	0%	79.8%
Vaxcel Pasv Picc	3	0	0.7%	86.4%
Bardia Foley Catheter Silicone Coated	2	193	0%	86.3%
AngioDynamics	1	14	1.7%	82.2%
Cadd Ms3 Pump	1	0	0%	93.7%
Fresenius Dialysis Delivery System	1	0	11%	60.4%
Mahurkar Elite	1	10	3.3%	82.2%
Minilink Transmitter Transmitter And Sensor Mmt-7002	1	0	0%	98.9%
On-Q Painbuster	1	0	0.6%	4.3%
Premicath	1	54	3.6%	69.8%
Xmtr MMT-7811NA GST3C Lockout	1	65	0%	99.5%

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
C R Bard Basd -3006260740	2,044	17.8%
Covidien	1,963	17.1%
Medcomp	1,198	10.5%
Bard Access Systems	1,169	10.2%
Covidien Mfg Solutions	913	8%
Arrow International	760	6.6%
C R Bard Basd	487	4.3%
Angiodynamics	338	2.9%
Merit Medical Systems	204	1.8%
Arrow Intl	162	1.4%
C R Bard	35	0.3%
Horizon Medical Products	26	0.2%
Bard	6	0.1%
Boston Scientific	5	0%
Fresenius USA	2	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

Death2.6%302

Injury20%2,295

Malfunction75.8%8,686

Other1.1%124

Not given0.4%51

Who filed

Manufacturer report94.7%10,853

Voluntary report2.5%282

User facility report0%0

Distributor report0%5

Not given2.8%318

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,299	11.3%
Fluid/blood leak	1,191	10.4%
Crackthe device cracked	1,082	9.4%
Leak/splashthe device leaked	989	8.6%
Explanted	875	7.6%
Fracturea broken bone	772	6.7%
Deformation due to compressive stress	468	4.1%
Material separation	444	3.9%
Material deformation	392	3.4%
Replace	384	3.4%
Defective component	373	3.3%
Material puncture/hole	362	3.2%
Hole in material	337	2.9%
Detachment of device component	334	2.9%
Difficult to removethe device was hard to remove	245	2.1%
Restricted flow rate	237	2.1%
Detachment of device or device componentpart of the device came off	233	2%
Migration or expulsion of device	219	1.9%
Material opacification	183	1.6%
Stretched	175	1.5%

Questions about catheter, hemodialysis, implanted reports

What is product code MSD?

FDA's classification code for "Catheter, hemodialysis, 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?

11,458 reports through August 2026, 824 of them in the latest 12 months.

Which brands appear most often?

Palindrome (1,402), GlidePath (774), HemoStar (360), Lifesite Hemodialysis Access System (342) and Equistream Split Tip (295). 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.