PROWLER 606-151JXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028604), received between Mar 9, 2017 and Mar 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance” (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 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.

• MalfunctionMar 9, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY PROCEDURE OF THE MIDDLE CEREBRAL ARTERY (M1), A PRESET LITE 3-20 (PHENOX) BECAME STUCK IN THE PROWLER 14 MICROCATHETER (606151JX/17448164). IT WAS REPORTED THAT AN INTERNAL LUMEN OF .0165¿ IS NEEDED FOR THE PRESET. THE PROWLER WAS EXCHANGED FOR AN SL-10 MICROCATHETER AND THE PRESET COULD EASILY BE PUSHED THROUGH. AN ADEQUATE CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE RESISTANCE OCCURRED BEYOND THE HUB, BUT SAFELY IN FRONT OF THE MID CATHETER. THE CATHETER HAD NOT BEEN RE-SHAPED AND DID NOT APPEAR DAMAGED. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE OR PATIENT HARM REPORTED. IT WAS REPORTED THAT THE PRESET DEVICE WILL NOT BE RETURNED; HOWEVER, THE PROWLER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390839 ↗

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 · 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