PROWLER SELECT 606-S155JXRecalls & reported problems
Medos International Sàrl · PROWLER SELECT LP ES TIP MARKERS 2 TIPSHAPE J Infusion Catheter 2.3F (0.75mm) 1.9F (0.65mm) .0165 Inch (0.4mm) 5cm 150cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (.9mm) · Class 2
All models of PROWLER SELECT (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704028789), received between Jul 30, 2018 and Mar 2, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K021591); 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
- Crack1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2020Crack; Crack
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF THE 150CM X 5CM, 2 MARKERS, J TIP PROWLER SELECT LPES MICROCATHETER (606S155JX / 30187163) WAS CRACKED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9775775 ↗MalfunctionJul 30, 2018Physical Resistance/Sticking; Physical Resistance/Sticking
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE ORBIT GALAXY COMPLEX XTRASOFT COIL 2MM X 2CM (640CX0202 / 30006827) COULD NOT BE ADVANCED THROUGH THE PROWLER SELECT LPES, 150CM X 5CM, 2 MARKERS, J TIP MICROCATHETER (606S155JX / 17680649). THERE WAS NO KINK OR BENT OBSERVED ON THE MICROCATHETER PRIOR TO THE REPORTED IMPEDED ISSUE ENCOUNTERED WITH THE MICROCATHETER. THE DEVICE WAS PREPPED AND USED PER THE INSTRUCTION FOR USE (IFU) WITH ADEQUATE AND CONTINUOUS FLUSH MAINTAINED THROUGH THE CATHETER. THE PHYSICIAN REPLACED BOTH THE COIL AND THE MICROCATHETER AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PROCEDURAL DELAY AND THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7733329 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021591. One submission often covers many models, so check the product and lot details in each record.
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.
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