PROWLER SELECT 606-S252XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028840), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 11, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE USING THE Y-STENT TECHNIQUE TO TREAT A BIFURCATION ANEURYSM AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), THE 150CM X 15CM PROWLER SELECT PLUS MICROCATHETER (606S252X / 30066727) WAS PROPERLY POSITIONED AT THE TARGET POSITION AND USED WITH TWO 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICES (ENC452212) FROM THE SAME LOT (10906474). THE FIRST ENTERPRISE STENT COULD NOT BE INTRODUCED INTO THE MICROCATHETER. THE SECOND ENTERPRISE STENT WAS SUCCESSFULLY INTRODUCED INTO THE MICROCATHETER, BUT THE DELIVERY WIRE WAS MET WITH RESISTANCE AND COULD NOT BE ADVANCED. THE PROWLER SELECT PLUS WAS REPLACED WITH THE VASCO MICROCATHETER (AIT BALT) AND THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE FROM LOT 10911251 WAS SUCCESSFULLY INTRODUCED INTO THE MICROCATHETER AND SUCCESSFULLY POSITIONED AND DEPLOYED AT THE TARGET SITE AND THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT. IT WAS REPORTED THAT THE PROWLER SELECT PLUS MICROCATHETER IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152404 ↗

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.

• Z-1482-06 · Aug 11, 2006 · Terminated
  Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
• Z-1483-06 · Aug 11, 2006 · Terminated
  Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.