PROWLER 606-2510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028680), received between Oct 29, 2019 and Oct 29, 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 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.

• MalfunctionOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 5X33 EMBOTRAP II STENT RETRIEVER (ET007533, 19G123AV) BECAME ¿STUCK¿ INTO THE 021 PROWLER SELECT MICROCATHETER (6062510, 30187162). THE DEVICE WAS NOT ABLE TO MOVE WITHIN THE MICROCATHETER. DUE TO THE RESISTANCE, THE MICROCATHETER WAS REMOVED AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THE DEVICES WERE FLUSHED WITHOUT DIFFICULTIES BEFORE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN USING ANOTHER SET OF DEVICES. THE EMBOTRAP NOR THE PROWLER SELECT APPEARED DAMAGED. THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THE TECHNIQUE USED TO HOLD THE INSERTION TOOL IN POSITION DURING ADVANCEMENT OF THE DEVICE WAS CORRECT. THE DEVICE WAS ABLE TO ADVANCE THROUGH THE HUB. ONE PASS HAD BEEN ATTEMPTED TO RETRIEVE THE CLOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249831 ↗

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