Biopsy needle: medical device reports filed with FDA

4,933 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.

4,933
reports with this product code: 0% of all MAUDE reports; 704
reports, 12 months to August 2026: 568 in the 12 months before; 78.4%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code FCG is FDA's classification for "Biopsy needle" (gastroenterology, Urology panel), a class 2 device. 4,933 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

704 reports arrived in the 12 months to August 2026, up 24% from 568 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 (78.4%), injury (20.6%) and death (0.5%). 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
Echotip Ultra Endoscopic Ultrasound Needle	654	49	0%	91.2%
Echotip Procore High Definition Ultrasound Biopsy Needle	548	27	0%	78%
Magnum Needle	448	206	0%	91.7%
Single Use Aspiration Needle NA-U401SX	416	195	0.2%	80.8%
Single Use Aspiration Needle	396	144	0.4%	79.4%
EchoTip ProCore Endobronchial HD Biopsy Needle	295	40	0%	58.6%
Interject	227	8	0.4%	99.1%
Echotip Ultra Endobronchial Hd Ultrasound Needle	189	24	0%	67%
Single Use Injector	21	40	0%	95.5%
Olympus	6	9	2.5%	69.7%
Evolution Biliary Controlled-Release Stent - Fully Covered	4	99	0.2%	83.7%
Zimmon Biliary Stent Set	4	34	0%	95.3%
Zimmon Biliary Stent	3	45	0%	93.8%
Zimmon Pancreatic Stent	2	6	0%	85.3%
Cook	1	6	2.2%	45%
Cotton-Leung Biliary Stent	1	20	1.1%	55.7%
Medline	1	26,184	0.1%	97.9%
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter	1	58	0%	57.7%

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
Cook Ireland	1,806	36.6%
Bard Peripheral Vascular	732	14.8%
Aomori Olympus	553	11.2%
Boston Scientific - Spencer	149	3%
Gyrus Acmi	131	2.7%
Carefusion	60	1.2%
Olympus Medical Systems	60	1.2%
Wilson-Cook Medical	57	1.2%
Cook Endoscopy	42	0.9%
Vascular Solutions	38	0.8%
Merit Medical Systems	13	0.3%
Allegiance Healthcare	7	0.1%
Cook	7	0.1%
C R Bard	3	0.1%
Bd	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

Death0.5%27

Injury20.6%1,017

Malfunction78.4%3,867

Other0.2%9

Not given0.3%13

Who filed

Manufacturer report92.6%4,569

Voluntary report2%98

User facility report0%0

Distributor report1.4%69

Not given4%197

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,307	26.5%
Fracturea broken bone	418	8.5%
Material twisted/bent	390	7.9%
Retraction problem	332	6.7%
Improper or incorrect procedure or method	227	4.6%
Detachment of device or device componentpart of the device came off	197	4%
Misfire	171	3.5%
Bent	166	3.4%
Off-label use	164	3.3%
Occlusion within devicethe device blocked	158	3.2%
Difficult to removethe device was hard to remove	146	3%
Device contamination with chemical or other material	119	2.4%
Physical resistance/sticking	118	2.4%
Detachment of device component	103	2.1%
Loose	90	1.8%
Material separation	90	1.8%
Kinkedthe tube or line kinked	79	1.6%
Material perforation	79	1.6%
Failure to advance	65	1.3%
Material puncture/hole	64	1.3%

Questions about biopsy needle reports

What is product code FCG?

FDA's classification code for "Biopsy needle", 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?

4,933 reports through August 2026, 704 of them in the latest 12 months.

Which brands appear most often?

Echotip Ultra Endoscopic Ultrasound Needle (654), Echotip Procore High Definition Ultrasound Biopsy Needle (548), Magnum Needle (448), Single Use Aspiration Needle NA-U401SX (416) and Single Use Aspiration Needle (396). 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.