PROWLER 606-2510XRecalls & reported problems
Medos International Sàrl · PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 3cm 20 cm 150 cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm) · Class 2
All models of PROWLER (8)
Data updated Oct 18, 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 10886704028727), received between Apr 12, 2019 and Apr 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
1 other recall cover devices cleared under the same FDA submission (K003925, 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 18, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN USED A NEVA¿ STENT RETRIEVER (VESALIO) AND MADE TWO ATTEMPTS TO DELIVER THE DEVICE THROUGH THE 150CM X 20CM DUAL MARKERS PROWLER PLUS MICROCATHETER (6062510X / 30003701), BUT THE DEVICE BECAME STUCK IN THE HUB OF THE PROWLER PLUS MICROCATHETER. THE NEVA¿ STENT RETRIEVER WAS REPLACED WITH AN EMBOTRAP REVASCULARIZATION DEVICE (CATALOG/LOT NUMBERS UNKNOWN) AND THE EMBOTRAP DEVICE WAS REPORTED TO BECOME STUCK IN THE SAME PLACE; IT COULD NOT CROSS THE DISTAL PART OF THE MICROCATHETER HUB. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATIONS. ADDITIONAL INFORMATION RELATED TO THE EVENT WAS REQUESTED AND WAS REPORTED TO BE UNAVAILABLE. THE PROWLER PLUS WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8510509 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K003925, K993266. One submission often covers many models, so check the product and lot details in each record.
- Z-0018-04 · Oct 19, 2001 · TerminatedProduct 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
Other Catheter, continuous flush devices
- PROWLER SELECT 606-S255XMedos International Sàrl · Catheter, continuous flush2 deaths980 reports
- PhenomTM 27 Catheter FG15150-0615-1SMicro Therapeutics, Inc. · Catheter, continuous flush2 deaths139 reports
- MarathonTM 105-5056Micro Therapeutics, Inc. · Catheter, continuous flush124 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page