PROWLER SELECTRecalls & reported problems across all models
Medos International Sàrl · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,066
- Deaths reported
- 3
- Injuries reported
- 27
- Recalls
- 0
We found 9 models of PROWLER SELECT by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 1,066 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2016 and Sep 30, 2026 — classified as 3 deaths, 27 injuries, 1,036 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (981 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PROWLER SELECT problems
Device problems
- Physical Resistance/Sticking981
- Material Twisted/Bent57
- Physical Resistance41
- Obstruction of Flow14
- Adverse Event Without Identified Device or Use Problem9
- Material Deformation9
- Contamination /Decontamination Problem6
- Crack6
Patient problems
- No Clinical Signs, Symptoms or Conditions928
- No Consequences Or Impact To Patient122
- Thromboembolism3
- Unspecified Nervous System Problem3
- Encephalopathy2
- Extravasation2
- Hemorrhage/Blood Loss/Bleeding2
- Intracranial Hemorrhage2
PROWLER SELECT models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROWLER SELECT 606-S255XCatheter, continuous flush2 deaths980 reports
- PROWLER SELECT 606-S255FXCatheter, continuous flush43 reports
- PROWLER SELECT 606-S155FXCatheter, continuous flush13 reports
- PROWLER SELECT 606-S155XCatheter, continuous flush13 reports
- PROWLER SELECT 606-S252Catheter, continuous flush1 death8 reports
- PROWLER SELECT 606-S272XCatheter, continuous flush4 reports
- PROWLER SELECT 606-S155JXCatheter, continuous flush2 reports
- PROWLER SELECT 606-S255MXCatheter, continuous flush2 reports
- PROWLER SELECT 606-S252XCatheter, continuous flush1 report
Recent PROWLER SELECT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947908 ↗MalfunctionSep 29, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933872 ↗MalfunctionSep 23, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873094 ↗MalfunctionSep 23, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872982 ↗MalfunctionSep 23, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871933 ↗MalfunctionSep 23, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869694 ↗MalfunctionSep 15, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776614 ↗MalfunctionSep 15, 2026Difficult to Advance; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776611 ↗MalfunctionSep 11, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736667 ↗MalfunctionSep 10, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714216 ↗MalfunctionSep 9, 2026Physical Resistance/Sticking
The healthcare professional reported that during a thrombectomy procedure targeting a right middle cerebral artery occlusion, the 150cm x 5cm Prowler Select Plus microcatheter (606S255X / 31815458) was in place and the stent (unspecified brand) was impeded in the proximal end of the microcatheter and could not advance further. The physician removed the stent and the microcatheter from the patient and replaced the microcatheter to deliver the original stent to complete the procedure, which was prolonged by about 10 minutes. There was no report of any negative patient impact.On 03-Sep-2026, additional information was received. The information confirmed that the thrombectomy procedure was targeting a right middle cerebral artery occlusion. A continuous flush was maintained through the microcatheter. There was no damage noted on the microcatheter that may have caused the stent to become obstructed. The replacement microcatheter was another 150cm x 5cm Prowler Select Plus microcatheter (606S255X). The information also confirmed there was no negative impact to the patient and no delay to the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695008 ↗MalfunctionSep 9, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694169 ↗MalfunctionSep 1, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548776 ↗MalfunctionAug 31, 2026Physical Resistance/Sticking
A healthcare professional reported that during an endovascular embolization, when delivering a 4.5MMD 22MML ENTERPRISE Vascular Reconstruction Device (product code: ENC452200, lot number: 9682206), the stent became impeded in the distal end of a PROWLER SELECT PLUS 150/5CM Microcatheter (product code: 606S255X, lot number: 31874892) and could not pass through the microcatheter (MC). The doctor removed the stent and microcatheter from the patient and then sequentially switched to a second microcatheter, aPROWLER SELECT PLUS 150/5CM (product code: 606S255X, lot number: 31519699) to deliver the original stent. The original stent was still impeded in the distal end of the second and third microcatheter and could not pass through the second and the third microcatheter. Finally, the doctor only retracted the original stent alone and switched to a second stent to complete the surgery. The third microcatheter was not replaced. The surgery was prolonged by about 15 minutes. Does surgeon have an extra set of hands to support while flushing aligning the Enterprise system was answered as ¿yes¿. Is a push plunge RHV being used was answered as ¿twisted type¿. Is there force needed to remove the
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524645 ↗MalfunctionAug 27, 2026Physical Resistance/Sticking
The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 23mm Enterprise 2 (ENCR402312 / 10071618) was impeded in the distal end of the associated 150cm x 5cm Prowler Select Plus microcatheter (606S255X / 31877599) and could not pass through the microcatheter. The physician removed the stent, which was still inside the microcatheter, and the microcatheter from the patient and replaced both devices with devices from different manufacturers to complete the procedure. There was no report of any negative patient impact.On (b)(6) 2026, additional information was received. Per the information, the procedure was targeting the middle cerebral artery (MCA). The information indicated that there was resistance during the advancement of the stent; the stent was impeded in the distal end of the microcatheter during the procedure. Continuous flush was maintained through the microcatheter. The flush was heparinized saline. There was no damage noted on the microcatheter. There was no negative patient impact and no delay to the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487258 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- GRYPHON ORTHOCORD6 models · 918 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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