PROWLER 606-151XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704028628), received between Feb 26, 2018 and Mar 20, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, BEFORE THE START OF THE PROCEDURE, THE PHYSICIAN INSPECTED THE PACKAGING OF THE 125CM LARGE BORE 71 CATHETER (IC71125UG / 31332260) AND OF THE ACTUAL LARGE BORE CATHETER. BOTH WERE IN GOOD CONDITION. AFTER THE PHYSICIAN SUCCESSIVELY DELIVERED A CEREBASE CATHETER (UNKNOWN CATALOG / LOT #), THE LARGE BORE CATHETER, AND THE PROWLER 14 DUAL MARKERS MICROCATHETER (606151X / 31178999) TO THE LESION SITE, THE COIL (UNSPECIFIED BRAND) WAS DETACHED IN THE TARGET SITE. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE DELIVERY WIRE OF THE COIL, THE DELIVERY WIRE WAS IMPEDED IN THE TIP OF THE PROWLER 14 MICROCATHETER TIP AND COULD NOT BE RETRACTED. THE PHYSICIAN REMOVED THE DELIVERY WIRE AND MICROCATHETER FROM THE PATIENT. IT WAS REPORTED THAT, ¿AT THIS TIME, THE PROXIMAL END (NOT IN THE PATIENT¿S BODY) OF THE LARGE BORE CATHETER WAS FOUND SLIGHTLY KINKED / BENT. THE PHYSICIAN ONLY REPLACED THE PROWLER 14 MICROCATHETER TO COMPLETE THE PROCEDURE, WHICH WAS PROLONGED BY APPROXIMATELY 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON (B)(6)2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654666 ↗
• MalfunctionJun 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AN EMBOLIC COIL (UNSPECIFIED BRAND) WAS IMPEDED IN THE 150CM PROWLER14 DUAL MARKERS MICROCATHETER (606151X / 31130286) AND COULD NOT ADVANCE AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL FROM THE PATIENT AND SWITCHED TO A NEW MICROCATHETER TO COMPLETE THE PROCEDURE USING THE ORIGINAL EMBOLIC COIL. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 30-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE RIGHT INTERNAL CAROTID ARTERY / POSTERIOR COMMUNICATING ARTERY. THE VESSEL WAS ¿MORE TORTUOUS.¿ IT WAS INDICATED THAT RESISTANCE WAS FIRST FELT DURING THE RE-SHEATHING OF THE DEVICE FOR RE-USE; IT WAS FELT INSIDE THE MICROCATHETER AT THE DISTAL SECTION. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING ADVANCEMENT. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS DAMAGED DURING DEVICE MANIPULATION, PUSHING THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590262 ↗
• MalfunctionOct 25, 2023Material Too Soft/Flexible; Physical Resistance/Sticking; Material Too Soft/Flexible; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE CERVICAL SEGMENT OF INTRACRANIAL ARTERY, A PROWLER-14 DUAL MARKER MICROCATHETER (606151X, 30802064) WAS PLACED IN TARGET SITE. THE PHYSICIAN DELIVERED AN UNSPECIFIED COIL INTO MICROCATHETER (MC) AND DETACHED THE COIL IN ANEURYSM. THE MICROCATHETER WAS FOUND TO BE MIGRATED INTO THE ANEURYSM. DOCTOR RETRACTED THE MICROCATHETER AND SWITCHED TO A NEW MICROCATHETER (OTHER BRAND) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 07-OCT-2023 INDICATED THAT THERE WAS NO RESISTANCE FELT AT ANY POINT DURING PROCEDURE. THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. THERE WAS NO DAMAGE TO THE MICROCATHETER DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003631 ↗
• MalfunctionJul 29, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE COATING ON THE INSIDE OF THE PROWLER14 DUAL MARKER 150CM MICROCATHETER (606151X / LOT# UNKNOWN) FLAKED OFF AND AS A RESULT, THE COIL, A 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2535 / LOT# UNK) WAS NOT ABLE TO ADVANCE THROUGH THE MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER. IT WAS ALSO REPORTED THAT NONE OF THE COATING FLAKES ENTERED THE PATIENT. THE PHYSICIAN REPLACED THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING THE SAME COIL. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341255 ↗
• MalfunctionSep 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL EMBOLIZATION TO THE LEFT ANTERIOR COMMUNICATING ARTERY, A 2.5 MM X 3.3 CM MICRUSFRAME10 COIL (MFR100253, L14834), DID NOT ADVANCE THROUGH THE PROWLER 14 MICROCATHETER (MC) DURING DELIVERY. THE USER REMOVED BOTH THE COIL AND THE MICROCATHETER AND USED NEW PROWLER AND COIL. AFTER THE CHANGE OF THE DEVICES, THE USER WAS ABLE TO CONTINUE WITH THE EMBOLIZATION WITH NO PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 20 MINUTES PROCEDURAL DELAY DUE TO THE EVENT. AFTER INSPECTION OF THE MICROCATHETER, IT LOOKS LIKE THE DISTAL PORTION WAS KINKED. NO EVIDENCE OF WHEN IT HAPPENED AND IF IT IS THE CAUSE OF THIS SITUATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH BEEN MAINTAINED THROUGH THE DEVICES. THE DEVICES DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICES. THE RHV IS NOT A PROBLEM, IT WASN´T TOO TIGHT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A SECOND MICRUSFRAME10 COIL (UNKNOWN PRODUCT CODE/LOT) DID NOT ADVANCE THROUGH A SECOND PROWLER-14 DUAL MARKER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993981 ↗
• MalfunctionJul 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL EMBOLIZATION TO THE LEFT ANTERIOR COMMUNICATING ARTERY, A 2.5 MM X 3.3 CM MICRUSFRAME 10 COIL (MFR100253, L14834), DID NOT ADVANCE THROUGH THE PROWLER 14 MICROCATHETER (MC) DURING DELIVERY. THE USER REMOVED BOTH THE COIL AND THE MICROCATHETER AND USED NEW PROWLER AND COIL. AFTER THE CHANGE OF THE DEVICES, THE USER WAS ABLE TO CONTINUE WITH THE EMBOLIZATION WITH NO PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 20 MINUTES PROCEDURAL DELAY DUE TO THE EVENT. AFTER INSPECTION OF THE MICROCATHETER, IT LOOKS LIKE THE DISTAL PORTION WAS KINKED. NO EVIDENCE OF WHEN IF HAPPENED AND IF IT IS THE CAUSE OF THIS SITUATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH BEEN MAINTAINED THROUGH THE DEVICES. THE DEVICES DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICES. THE RHV IS NOT A PROBLEM, IT WASN´T TOO TIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773243 ↗
• MalfunctionFeb 5, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTERVENTIONAL EMBOLIZATION OF A POSTERIOR COMMUNICATION ARTERY ANEURYSM, THE FIRST TWO COILS: A 5 MM X 17 CM PRESIDIO 10 CERECYTE (PC410051730/S12276) AND A 2 MM X 6 CM DELTAPAQ 10 CERECYTE (CDF10020630/S37678) ADVANCED SMOOTHLY WITHOUT ANY ISSUE THROUGH THE 150 CM PROWLER14 MICROCATHETER (606151X/LOT# UNKNOWN). THE THIRD COIL CHOSEN WAS THE 3 MM X 6 CM CASHMERE 14 CERECYTE COIL (CRC14030630/S13696). WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THIS COIL TO THE TARGET SITE FOR IMPLANTATION, HE FOUND IT HARD TO PUSH THE COIL IN THE MICROCATHETER. IT WAS ALSO HARD TO PULL THE COIL BACK OUT FROM THE MICROCATHETER. THE PHYSICIAN COULD ONLY PULL THE CASHMERE 14 CERECYTE COIL OUT WITH THE PROWLER 14 MICROCATHETER. THE EVENT RESULTED IN THE LOSS OF THE TARGET SITE AS BOTH THE COIL AND THE MICROCATHETER WERE REPLACED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8308404 ↗
• MalfunctionFeb 26, 2018Physical Resistance; Physical Resistance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM ON THE INTERNAL CAROTID ARTERY, THE PHYSICIAN DEPLOYED THE ORBIT GALAXY G2 3X4 COIL THROUGH THE PROWLER-14 DUAL MAKER MICROCATHETER (606151X / 17488447) IN ATTEMPT TO COIL THE ANEURYSM, BUT THE COIL ENCOUNTERED RESISTANCE. THE PHYSICIAN EXCHANGED THE TO ANOTHER PROWLER-14 MICROCATHETER AND SUCCESSFULLY DEPLOYED THE COIL. A TOTAL OF 8 COILS WERE DEPLOYED AFTER THE FIRST COIL. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297766 ↗

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