Devices › Catheter for crossing total occlusions

Device brand name · Recanalization catheter

Crosser: medical device reports filed with FDA

364 reports name it, 2015–2026. Manufacturer given most often on reports: Bard Peripheral Vascular. Product code PDU.

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.

364
device reports naming the brand: 0% of all MAUDE reports · about 32 a year; 57
reports, 12 months to August 2026: 70 in the 12 months before; 97%
classified as malfunction: 90.3% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

364 medical device reports received by FDA name the brand "Crosser" (recanalization catheter); the manufacturer given most often on reports is Bard Peripheral Vascular; received from January 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

57 reports arrived in the 12 months to August 2026, down 19% from 70 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 (97%), injury (2.7%) and other (0.3%); across all catheter for crossing total occlusions reports (product code PDU) death is recorded in 0.1% and malfunction in 90.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material separation (60.2%), detachment of device or device component (36%) and material deformation (9.1%). The patient problems coded most often are foreign body in patient, appropriate clinical signs, symptoms and conditions term/code not available and hemorrhage/blood loss/bleeding. 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."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury2.7%10

Malfunction97%353

Other0.3%1

Not given0%0

Who filed the report

Manufacturer report99.2%361

Voluntary report0.3%1

User facility report0%0

Distributor report0%0

Not given0.5%2

Grey bar: all 1,386 reports carrying product code PDU. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Material separation	219	60.2%	47%
Detachment of device or device componentpart of the device came off	131	36%	24.3%
Material deformation	33	9.1%	6.6%
Device-device incompatibility	30	8.2%	9.8%
Breakthe device broke	28	7.7%	6.4%
Material split, cut or torn	25	6.9%	4.4%
Failure to advance	21	5.8%	4.8%
Leak/splashthe device leaked	19	5.2%	2.3%
Material frayed	16	4.4%	1.7%
Activation problem	14	3.8%	3.2%
Retraction problem	14	3.8%	8.1%
Material twisted/bent	11	3%	4.6%
Peeled/delaminated	8	2.2%	1.7%
Fracturea broken bone	7	1.9%	9.9%
Connection problema connection problem	6	1.6%	0.8%
Difficult to removethe device was hard to remove	6	1.6%	3.2%
Improper or incorrect procedure or method	5	1.4%	0.6%
Crackthe device cracked	3	0.8%	0%
Flushing problem	3	0.8%	0.4%
Material puncture/hole	3	0.8%	1.4%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Foreign body in patientpart of a device left in the patient	7	1.9%
Appropriate clinical signs, symptoms and conditions term/code not available	2	0.5%
Hemorrhage/blood loss/bleeding	1	0.3%
Vascular dissection	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Crosser	Product code PDU	All MAUDE reports
Reports	364	1,386	26,136,888
Share of that pool	—	26.3%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	2.7%	9.5%	36.2%
Classified as malfunction	97%	90.3%	62.3%
Filed by the manufacturer	99.2%	97.9%	94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code PDU

Brand	Reports	Classified as death
Crosser Cto Recanalization Catheter	362	0.3%
Crosser Cto Recanalization Catheters	223	0%
Crosser Recanalization Catheter	159	1.3%
Outback Re-Entry Catheter	275	0%
Bd	191	1%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Crosser reports

How many FDA reports name Crosser?

364 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.

What kinds of events are reported?

malfunction (97%), injury (2.7%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material separation (60.2%), detachment of device or device component (36%), material deformation (9.1%), device-device incompatibility (8.2%) and break (7.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.2%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Crosser was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.