PROWLER 606-171Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704028635), received between Aug 20, 2024 and Apr 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K003925, K972518, 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. 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.

• InjuryApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED, VIA A HEALTH AUTHORITY, THAT A PROWLER-14 170CM MICROCATHETER (606171/ 31512439) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE TIP OF THE MICROCATHETER BECAME STUCK TO THE VESSEL AFTER ADMINISTERING A LIQUID EMBOLIC AGENT TO THE TARGET SITE. WHEN ATTEMPTING TO WITHDRAW THE GLUED TIP FROM THE VESSEL, THE CATHETER STRETCHED AND SEPARATED. AS A RESULT, THE PHYSICIAN ¿TUCKED¿ THE RETAINED PORTION OF THE MICROCATHETER (APPROXIMATELY 3-4 INCHES IN LENGTH) INTO THE EXTERNAL CAROTID ARTERY AND PRECLUDE FURTHER COMPLICATIONS. THE EVENT WAS REPORTED AS SUCH, ¿DURING THE ANGIOGRAM, THE PHYSICIAN WAS ADMINISTERING GLUE (EMBOLIC FLUID) TO THE TARGET VESSEL AND REPORTED THAT HE GOT SOME FLUSH OF FLUID BACK TOWARDS THE CATHETER AND THE GLUE HIT THE TIP OF THE CATHETER AND STUCK TO IT. IN AN EFFORT TO WITHDRAW THE CATHETER FROM THE GLUE, THE CATHETER STRETCHED AND UNFORTUNATELY FRACTURED. WE DO NOT KNOW THE EXACT MEASUREMENT OF THE RETAINED CATHETER, BUT IT IS APPROXIMATELY 3-4 INCHES. THE REMAINDER OF THIS CATHETER WAS TUCKED INTO THE EXTERNAL CAROTID ARTERY (ECA) WHERE IT WILL NOT CAUSE ANY ISSUES GOING FORWARD PER MD AND NO FLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918750 ↗
• MalfunctionAug 20, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED BY THE FIELD, DURING THE PREPPING OF A PROWLER-14 170CM MICROCATHETER (606171, 31083013), THE PHYSICIAN FELT THE CATHETER AND THE TIP FELT TEXTURED INSTEAD OF SMOOTH. THE CATHETER WAS NOT USED IN THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-AUG-2024 INDICATED THAT THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. IT WAS NOTED THAT THE REPORTED CONDITION MIGHT BE A RESULT OF A DELAMINATED OR CRACKED COATING. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO BREAK IN DEVICE INTEGRITY AT THE SITE OF THE DEFECT, LEADING TO POTENTIAL SEPARATION INTO TWO OR MORE SEPARATE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002098 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003925, K972518, 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