PROWLER SELECT 606-S255MXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704028871), received between Dec 30, 2016 and Jul 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, A PROWLER SELECT PLUS 5CM 90 TIP MICROCATHETER (606S255MX, 30118145) WAS USED TO IMPLANT A PULSE RIDER (PRODUCT CODE/ LOT NUMBER UNKNOWN). HOWEVER, RESISTANCE BECAME STRONGER AND STRONGER AFTER THE PULSERIDER REACHED THE HUB. IT GOT STUCK ON THE 30 CM FROM THE DISTAL END. THE PULSERIDER WAS REMOVED AND THE COMPLAINT MICROCATHETER (MC) WAS FLUSHED. THE PHYSICIAN TRIED AGAIN BUT THE SAME ISSUE CONTINUED. THE COMPLAINT MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER. THE PULSERIDER WAS ABLE TO BE SMOOTHLY DELIVERED THROUGH THE REPLACED DEVICE AND IMPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE MC DURING MANIPULATION OR UPON REMOVAL FROM THE PATIENT. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE TARGET LESION BEING TREATED WAS THE BASILAR ARTERY TOP (BA). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203527 ↗
• MalfunctionDec 30, 2016Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR THE DIREMPTION OF THE INTERNAL CAROTID ARTERY, AN ENTERPRISE (ENF403900/10571456) WAS DELIVERED INTO THE PROWLER SELECT PLUS (606S255MX/16066293), BUT IT GOT STUCK AT APPROXIMATELY 15CM FROM ITS TIP. THE ENTERPRISE WAS REMOVED FROM THE MICROCATHETER AND THE CATHETER WAS REPLACED WITH ANOTHER ONE. THE SAME ENTERPRISE WAS USED SUCCESSFULLY AFTER REPLACED THE MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES; HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 30 MINUTES. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. IT WAS REPORTED THAT THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE PATIENT¿S VESSEL WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215893 ↗

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