PROWLER 606-051XRecalls & reported problems

Medos International Sàrl · PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015 Inch (0.4 mm) 3cm 50 cm 150 cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (0.9 mm) · Class 2

All models of PROWLER (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028550), received between May 26, 2026 and May 26, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K003925, K972518, K993266); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 26, 2026Fluid/Blood Leak
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE 10CM X 150CM DUAL MARKERS PROWLER 10 (606051X / 31700155) WITH SALINE AND OBSERVED THAT FLUID ESCAPED FROM THE SITE NEAR THE MICROCATHETER HUB. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT¿S BODY AND REPLACED IT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 22-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A MIDDLE CEREBRAL ARTERY ARTERIOVENOUS MALFORMATION. THE REPLACEMENT DEVICE WAS ANOTHER 10CM X 150CM DUAL MARKERS PROWLER 10 (606051X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25284663 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003925, K972518, K993266. One submission often covers many models, so check the product and lot details in each record.

Z-0018-04 · Oct 19, 2001 · Terminated
Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual

Device details

UDI-DI	`10886704028550`
Brand	PROWLER
Model	606-051X
Catalog no.	606051X
Company	Medos International Sàrl
Product code	KRA · Catheter, continuous flush
Class	Class 2
FDA submission	K003925, K972518, K993266
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 4, 2020

Device type (GMDN): Vascular microcatheter

A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

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All Catheter, continuous flush devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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