PROWLER SELECT 606-S155FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704028772), received between Nov 1, 2016 and Feb 9, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Peeled/Delaminated

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (PRODUCT CODE: 606S155FX, LOT NUMBER: UNKNOWN) INNER COATING WAS PEELED OFF. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291837 ↗
• InjuryApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED, VIA A HEALTH AUTHORITY REPORT, THAT A PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (606S155FX/ 31411524) WAS USED FOR A NEUROINTERVENTIONAL TRANSCATHETER EMBOLIZATION. DURING THE PROCEDURE, THE USER REPORTED THE DISTAL TIP OF THE CATHETER SEPARATED WHILE IN PATIENT. THE FRAGMENT WAS LEFT IN PATIENT, AS THE PHYSICIAN WAS UNABLE TO SAFELY REMOVE IT. NO FURTHER DETAILS WERE PROVIDED. THE EVENT WAS REPORTED AS SUCH, ¿WHILE UNDERGOING A NEUROINTERVENTIONAL TRANSCATHETER EMBOLIZATION ON (B)(6) 2024 THE CATHETER TIP FRACTURED IN THE LEFT COMMON CAROTID ARTERY. THE CATHETER TIP FRAGMENT WAS RETAINED AS THE PROVIDER WAS UNABLE TO SAFELY REMOVE IT AND THE RISK OUTWEIGHED THE BENEFIT OF DOING SO.¿

  Patient problems: Insufficient Information

  MAUDE report 21740831 ↗
• MalfunctionAug 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS RESISTANCE WHILE PUSHING AN ORBIT GALAXY COIL (640CF0412, 30842964) IN THE UNSPECIFIED MICROCATHETER (MC), WHEN THE COIL WAS REMOVED IT WAS STRETCHED. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED EVENT. ANOTHER COIL WAS USED TO COMPLETE THE SUCCESSFUL PROCEDURE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE MC USED, WAS A PROWLER SELECT LPES 45 DEG TIP (606S155FX, 30763314). THE RESISTANCE WAS ENCOUNTERED AT THE DISTAL SHAFT OF THE MC. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. THE EVENT DID RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING COIL ADVANCEMENT. NO EXCESSIVE FORCE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557205 ↗
• MalfunctionSep 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY AN ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0204 / 30723400) THROUGH A 150CM X 5CM, 45-DEGREE PROWLER SELECT PLUS MICROCATHETER (606S155FX / 30763314), BUT WHILE ADVANCING THE COIL MIDWAY THROUGH, THE PHYSICIAN ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO PUSH THE COIL FORWARD AND WAS UNABLE TO RETRACT THE COIL OUT FROM THE MICROCATHETER. AS A RESULT, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NEW COIL. ON 24-AUG-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE COMPLAINT DEVICES DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. BASED ON THE ADDITIONAL EVENT INFORMATION ON 24-AUG-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366777 ↗
• MalfunctionFeb 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, A GALAXY G3 XSFT COIL 4MM X 6CM (GLX120406, 30513170) COULD NOT EASILY BE INTRODUCED INTO A PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (606-S155FX, 30422138). WHEN PULLING THE COIL BACK TO INTRODUCE AGAIN INTO THE MICROCATHETER (MC), THE COIL BECAME STRETCHED. THE INTRACRANIAL PROCEDURE WAS FINISHED SUCCESSFULLY WITH A NEW PROWLER SELECT AND A NEW COIL. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441828 ↗
• MalfunctionFeb 19, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF THE 150CM X 5CM, 45 DEGREES PROWLER SELECT LPES MICROCATHETER (606S155FX / 30140219) WAS CRACKED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728187 ↗
• MalfunctionJun 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET SITE ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 150CM X 5CM, 45° TIP PROWLER SELECT LPES MICROCATHETER (606S155FX / 30140219) WAS INSERTED INTO THE PATIENT¿S BODY AND TWO FRAMING COILS WERE DELIVERED. WHEN THE 3MM X 8CM GALAXY G3 COIL (GLY120308 / L13283) WAS INSERTED, THERE WAS STRONG RESISTANCE FELT BETWEEN THE MICROCATHETER AND THE COIL. THE COIL WAS REMOVED FROM THE PATIENT AND THE MICROCATHETER WAS FLUSHED; THE GALAXY G3 COIL WAS REINSERTED BUT THE RESISTANCE WAS STILL EXPERIENCED. THE PROWLER SELECT LPES WAS REPLACED WITH THE SL-10® MICROCATHETER (STRYKER). THE INTRODUCER SHEATH OF THE GALAXY G3 COIL WAS DAMAGED AND THE COIL COULD NOT BE RESHEATHED AND THE COIL WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH COMPETITOR COIL. THERE WAS NO REPORT OF PATIENT COMPLICATIONS OR ADVERSE EVENT. THE PROWLER SELECT LPES MICROCATHETER WAS REPORTED AS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724518 ↗
• MalfunctionMar 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A NON-TORTUOUS PERICALLOSAL ARTERY ANEURYSM, THE 6F ENVOY DA GUIDE CATHETER WAS POSITIONED AND THE PROWLER SELECT LPES (606S155FX/17680646) MICROCATHETER AND NEUROSCOUT 14 STD (601314/HU8939) GUIDEWIRE WERE INTRODUCED, BUT THE GUIDEWIRE BECAME IMPEDED IN THE BODY/SHAFT OF THE MICROCATHETER NEAR THE SITE OF THE ANEURYSM AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE MICROCATHETER. MANEUVERS WERE MADE IN AN ATTEMPT TO ¿DROP¿ THE GUIDEWIRE FROM INSIDE OF THE MICROCATHETER, BUT THE PHYSICIAN ULTIMATELY DECIDED TO WITHDRAW THE GUIDEWIRE AND MICROCATHETER FROM THE GUIDE CATHETER AS A UNIT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE GUIDEWIRE WAS TRAPPED INSIDE OF THE MICROCATHETER AND THE DEVICES WERE ¿FIXED¿. THE GUIDEWIRE AND MICROCATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME ENVOY GUIDE CATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE LENGTH OF TIME THAT THE SURGERY WAS DELAYED DUE TO THE EVENT WAS NOT REPORTED; HOWEVER, THE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICES WERE STORED, PREPPED, AND FLUSHED ACCORDING TO THE I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462377 ↗
• MalfunctionAug 24, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A CEREBRAL ANEURYSM, THE MICRUSPHERE XL COIL (SSR18174020/ S11164) DETACHED INSIDE THE PROWLER SELECT LPES MICROCATHETER (606S155FX/17423598) DURING INITIAL USE OF THE PRODUCT, AND BOTH DEVICES WERE REMOVED FROM THE PATIENT WITHOUT CAUSING ANY DAMAGE OR EXPOSING THE PATIENT TO RISK. NEW DEVICES OF THE SAME TYPE WERE OPENED FOR CONTINUITY OF THE SURGICAL PROCEDURE. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816348 ↗
• MalfunctionAug 7, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL DURING THE PROCEDURE, RESISTANCE WAS EXPERIENCED WHEN A PRESIDIO10 COIL (PC410073030/C23504) AND A CASHMERE COIL (CRC14051230/S11722) WERE ADVANCED THROUGH A PROWLER CATHETER (606S155FX/17574497). INTRODUCER SHEATH OF BOTH THE PRESIDIO10 COIL AND THE CASHMERE COIL WERE ALSO DAMAGED. THE PROCEDURE WAS PRE-ENDOVASCULAR ANEURYSM REPAIR COIL EMBOLIZATION AT BRANCH(ES) OF THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT WAS A (B)(6)-YEAR-OLD MALE. THE PATIENT¿S VESSEL WAS HEAVILY TORTUROUS AND HEAVILY CALCIFIED. THE PRESIDIO10 COIL WAS DELIVERED HOWEVER RESISTANCE WAS EXPERIENCED WITH THE PROWLER CATHETER. REPORTEDLY THE DIAMETER OF THE PROWLER SELECT LPES WAS SMALL. THE INTRODUCER SHEATH OF THE PRESIDIO 10 COIL GOT DAMAGED DURING FRAMING. THEREFORE, IT WAS REPLACED WITH A CASHMERE COIL (CRC14051230/S11722), BUT THE SHEATH GOT DAMAGED AS WELL. THEREFORE, THE MICRO CATHETER WAS REPLACED WITH OTHER MICROCATHETER (SELECT PLUS), AND A NEW COIL WAS DELIVERED (PRESIDIO8*30). THE PROCEDURE WAS COMPLETED USING MICRUS COIL(S). EXCESSIVE FORCE WAS NOT USED WHEN HANDLING THE COMPLAINT COILS AND NO DIFFICULTY WAS EXPERIENCED WHEN HANDLING THE TWO COMPLAINT COILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6771615 ↗
• MalfunctionJul 13, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A NEUROSCOUT WIRE (601315/ H02189) GOT STUCK IN THE PROWLER SELECT PLUS MICROCATHETER LPES (606S155FX/ 17458599) AND BOTH DEVICES WERE EXCHANGED RESULTING IN LOSS OF TARGET POSITION. THE EVENT OCCURRED DURING AN ANTERIOR COMMUNICATING ARTERY PROCEDURE. NEITHER OF THE DEVICES APPEARED DAMAGED. THERE WAS NO REPORT OF PATIENT INJURY OF PROCEDURE DELAY AND IT WAS REPORTED THAT THE DEVICES WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710200 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING STENT ASSISTED COILING OF AN UNRUPTURED 6 X 4.5 MM MIDDLE CEREBRAL ARTERY ANEURYSM IN A (B)(6) YEAR OLD PATIENT, RESISTANCE WAS EXPERIENCED WHEN USING TWO GALAXY COILS (GLX123509/S11635 AND GLY120620/S11514). AFTER SUCCESSFULLY PLACING 23 MM ENTERPRISE 2 STENT, THE SURGEON PLACED A PROWLER LPES MICROCATHETER (606S155FX/16068713) INTO THE ANEURYSM. A 5X15 GALAXY G3 COIL WAS DECIDED TO BE PLACED. AFTER SUCCESSFULLY PLACING AND DETACHING THE COIL, THE SURGEON DECIDED TO PLACE A 3.5X9 G3 XTRASOFT COIL (LOT# S11635). UPON INTRODUCING THE COIL INTO THE LPES IT WAS NOTED THAT THERE WAS A FAIR AMOUNT OF RESISTANCE PUSHING THE COIL THROUGH THE MICROCATHETER. HE WAS HOWEVER ABLE TO SUCCESSFULLY PLACE AND DETACH THIS COIL. AT THIS TIME, THE SURGEON WAS SATISFIED WITH THE OCCLUSION OF THE ANEURYSM AND PULLED THE LPES OUT INTO M1. UPON FINAL ANGIOGRAM, A SLIGHT EXTRAVASATION IN THE M3 TO M4 DISTRIBUTION WAS NOTICED. THE SURGEON DECIDED AT THAT TIME TO TEMPORARILY OCCLUDE THE M1 WITH A 6X20 GALAXY G3 (LOT# S11514) AND TRIED TO ADVANCE THE COIL INTO THE MC BUT IT WOULD NOT ADVANCE. AFTER A COUPLE OF TRIES THE SURGEON ASKED FOR GALAXY 6

  Patient problems: Extravasation

  MAUDE report 6151058 ↗
• MalfunctionNov 1, 2016Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM AT THE RIGHT POSTERIOR COMMUNICATING ARTERY THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING THREE PRESIDIO COIL (PC410041230/LOT# C18183, C19118 AND C20979) AND A PROWLER SELECT PLUS CATHETER (606S155FX/17358075). THE ANEURYSM MEASURED 10 MM X 4 MM X 4 MM. A PROWLER SELECT LP ES WAS SELECTED AS THE MICRO CATHETER. THE ANEURYSM WAS ACCESSED WITHOUT INCIDENT USING A SYNCHRO GUIDE WIRE. THE PROWLER SELECT MICRO CATHETER WAS THEN TRACKED OVER THE WIRE AND INTO THE ANEURYSM WITHOUT INCIDENT. THE PHYSICIAN THEN ATTEMPTED TO INSERT A PRESIDIO MICROCOIL 4 X 11.5 (LOT# C18183). UPON INTRODUCTION INTO THE MICRO CATHETER RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL SHAFT OF THE CATHETER AND THE COIL WAS UNABLE TO BE PUSHED DISTALLY. THE PHYSICIAN THEN REMOVED THE PRESIDIO MICROCOIL. THE PHYSICIAN THEN USED THE SYNCHRO GUIDE WIRE TO RE-ACCESS THE ANEURYSM ENSURING THAT THE MICRO CATHETER LUMEN WAS INTACT. THE PHYSICIAN THEN RE-ATTEMPTED TO INTRODUCE THE PRESIDIO MICROCOIL WITHOUT SUCCESS, AS THE SAME RESISTANCE ISSUE WAS EXPERIENCED. THE PHYSICIAN THEN REQUESTED THAT A NEW PRESIDIO 4X11.5 MIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6069704 ↗

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.