PROWLER SELECT 606-S155XRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704028802), received between Jul 5, 2017 and Jun 13, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 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.

• MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM COIL EMBOLIZATION PROCEDURE, THE STENT (UNSPECIFIED BRAND) WAS IMPEDED IN THE PROWLER SELECT LPES (606S155X / 31028218) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE STENT, CHANGED THE GUIDEWIRE, AND DELIVERED THE STENT IN THE MICROCATHETER AGAIN AND ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE MICROCATHETER AND USED IT TO DELIVER THE ORIGINAL STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 07-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE STENT WAS AN ENTERPRISE 2 STENT (CATALOG / LOT# NOT PROVIDED). THE TARGET VESSEL WAS THE POSTERIOR INTERNAL CAROTID COMMUNICATING SEGMENT; TYPE II ARCH WITH TORTUOUS VESSELS. THE INFORMATION INDICATED THAT ¿THE STENT WAS IMPEDED AND COULD NOT BE SENT OUT, AND IT WAS FOUND THAT THE MICROCATHETER MAY BE DAMAGED AND COULD NOT PASS THROUGH. THEREFORE, THE MICROCATHETER WAS REPLACED.¿ THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER; A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533735 ↗
• MalfunctionJan 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS RESISTANCE WHILE PUSHING THE ORBIT GALAXY XTRASOFT COIL (640CX2535, 30758099) IN THE UNSPECIFIED MICROCATHETER (MC). WHEN THE COIL WAS REMOVED, IT WAS STRETCHED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A FIVE-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 13-JAN-2024 INDICATING THAT THE RESISTANCE WAS FIRST FELT INSIDE THE MID SHAFT OF THE PROWLER SELECT LPES LOT (606S155X, 31041133, LOT UNKNOWN) MICROCATHETER. BEFORE THE RESISTANCE, TWO COILS HAD BEEN USED AND AFTER THE ENCOUNTERED RESISTANCE, ONE COIL WAS USED. THE EVENT DID RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NOTHING 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 EXCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553205 ↗
• MalfunctionJan 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE PUSHING TWO 9MM X 30CM ORBIT GALAXY COMPLEX FRAME COILS (640CR0930) BOTH FROM LOT 30957434 IN THE MICROCATHETER. THE COILS WERE REMOVED. THE PROCEDURE WAS DELAYED BY 10 MINUTES; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THERE WERE NO REMARKABLE ANATOMICAL / VESSEL CHARACTERISTICS SUCH AS VESSEL CALCIFICATION AND/OR TORTUOSITY. THE MICROCATHETER USED WAS A PROWLER SELECT LPES MICROCATHETER (606S155X / 31041133). PER THE ADDITIONAL INFORMATION, THE REPORTED RESISTANCE AS FIRST FELT DURING ADVANCEMENT OF THE DEVICE INSIDE THE CONCOMITANT MICROCATHETER AT MID-SHAFT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. PRIOR TO THE REPORTED RESISTANCE, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 30856382) WAS SUCCESSFULLY USED WITH THE MICROCATHETER. THE MICROCATHETER WAS REMOVED WHEN THE RESISTANCE WAS ENCOUNTERED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509082 ↗
• MalfunctionNov 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX0406, 30692754) AND AN ORBIT GALAXY XTRASOFT COIL (640CX3505, 30706309) BECAME STUCK INTO A PROWLER SELECT LPES MICROCATHETER (606S155X, 31041133). IT WAS ALSO NOTED THAT THERE IS A THREAD INSIDE THE PACKING OF THE COIL. THE PROCEDURE WAS DELAYED BY 30 MINUTES. THE DEVICES WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. A NEW COIL AND MICROCATHETER (MC) WERE USED TO COMPETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121596 ↗
• MalfunctionSep 5, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0406 / 30651725) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT MICROCATHETER, A 150CM X 5CM, 2 MARKERS PROWLER SELECT LPES (606S155X / 30763317) AND COULD NOT PASS THROUGH. THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE. THE PHYSICIAN REMOVE THE COIL AND MICROCATHETER FROM THE PATIENT¿S ANATOMY AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT BOTH DEVICES WERE OBSERVED TO BE KINKED / BENT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS A LOBULATED ANEURYSM (ANEURYSM SIZE WAS UNOBTAINABLE) ON THE INTERNAL CAROTID ARTERY (ICA). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WAS SIGNIFICANT RESISTANCE WHEN THE COIL WAS APPROACHING THE TIP OF THE MICROCATHETER. NO OTHER COIL WENT THROUGH THE MICROCATHETER PRIOR TO THE COMPLAINT COIL. THE ISSUE REPORTED OCCUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684889 ↗
• MalfunctionMay 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE PHYSICIAN TRIED TO TRACK THE 150CM X 5CM PROWLER SELECT PLUS LPES MICROCATHETER (606S155X / 30339116) THROUGH A SYNCHRO2® GUIDEWIRE (STRYKER) AND REACH THE TARGET VESSEL. AFTER REACHING THE ACOM ANEURYSM, THE PHYSICIAN REMOVED THE GUIDEWIRE AND TRIED TO DEPLOY A 4MM X 12CM TARGET COIL (STRYKER) BUT EXPERIENCED RESISTANCE WHILE ADVANCING THE COIL. WITH MUCH DIFFICULTY, HE DEPLOYED THE COIL AND THEN HE TOOK A 3.5M X 8CM AXIUM¿ COIL (MEDTRONIC) AND FELT A LOT OF RESISTANCE DURING THE ADVANCEMENT OF THIS SECOND COIL. THIS TIME, THE COIL DID NOT TRACK THROUGH THE MICROCATHETER; IT ONLY WENT HALFWAY. AFTER A FEW ATTEMPTS, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL AND DEPLOYED THE 3.5M X 8CM AXIUM¿ COIL THROUGH AN ECHELON¿ MICROCATHETER (MEDTRONIC). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376773 ↗
• MalfunctionDec 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING ENDOVASCULAR ANEURYSM COIL EMBOLIZATION PROCEDURE, THE 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155X / UNKNOWN LOT) WAS PLACED IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THEN THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / UNKNOWN LOT) WAS USED TO COIL THE TARGET ANEURYSM. IT WAS REPORTED THAT THE COMPLAINT COIL GOT STUCK IN THE MICROCATHETER. THE COIL WAS REMOVED, BUT IT WAS OBSERVED STRETCHED. AS A RESULT, THE MICROCATHETER AND COIL WERE BOTH REMOVED. ANOTHER MICROCATHETER WAS PLACED AND THE ANEURYSM WAS COILED. THE REPORTED EVENT RESULTED IN A 20-MINUTE PROCEDURE DELAY. THE COIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PATIENT IS DOING FINE. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019453 ↗
• MalfunctionOct 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED COIL EMBOLIZATION OF ANEURYSMS, THE DELIVERY WIRE OF AN ENTERPRISE 4.5MMD X 22MML WITH NO DISTAL TIP (ENC452200 , 6357987 ) WAS NOT ABLE TO ARRIVE AT DISTAL OF A PROWLER SELECT LPES MICROCATHETER (606S155X, 30499442). THE MICROCATHETER WAS REMOVED. IT WAS FOUND TO BE KINKED, SWITCHED TO ANOTHER ONE. THE ENTERPRISE STENT WAS IMPEDED AND COULD NOT ADVANCE ANYMORE DURING ITS DELIVERY TO MICROCATHETER. THE PHYSICIAN INSPECTED AND OBSERVED THE STENT HAD RELEASED IN Y CONNECTOR, WITHDREW THE DEVICE, FOUND THE DELIVERY WIRE WAS BROKEN. CHANGED TO ANOTHER STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY. PICTURES HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646912 ↗
• MalfunctionSep 9, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AFTER A SUDDEN SEVERE HEADACHE FOLLOWED BY SYNCOPE DURING PHYSICAL EXERCISE, THE (B)(6) YEAR-OLD FEMALE PATIENT PRESENTED ON INTAKE CRANIAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED SPONTANEOUS SUBARACHNOID HEMORRHAGE, FISHER GRADE III, HUNT-HESS II, EVOLVING WITH COMA ONE HOUR AFTER HOSPITAL ADMISSION. THE PATIENT UNDERWENT AN EMERGENCY CEREBRAL ANGIOGRAPHY OF THE SIX VESSELS, FOLLOWED BY EMBOLIZATION OF A LARGE ANEURYSM IN AN OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155X / 30023533) WAS USED. THE FIRST COIL, A 12MM X 30CM CASHMERE 14 PLATINUM COIL (SRC14123020 / L12872) WAS BEING INTRODUCED INTO THE MICROCATHETER AND IT WAS NOTED THAT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER DURING COIL ADVANCEMENT ON THE INITIAL POSITIONING OF THE COIL THROUGH THE MICROCATHETER TO REACH THE TARGET ANEURYSM. AS A RESULT, IT WAS NOT VIABLE TO POSITION OR MANEUVER THE COIL WITHIN THE ANEURYSM. THE COIL BECAME STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL COMBINATION AND REPLACED BOTH THE COIL AND THE MICROCATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10511462 ↗
• MalfunctionJun 18, 2018Break; Entrapment of Device; Failure to Advance; Physical Resistance; Device Or Device Fragments Location Unknown

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM IN A (B)(6) MALE PATIENT WHO WAS ADMITTED WITH SUBARACHNOID HEMORRHAGE (SAH), THE ORBIT GALAXY TDL COMPLEX FRAME 7 X 25 COIL (640CR0725 / 17502571) BECAME STUCK IN THE PROWLER SELECT LPES MICROCATHETER (606S155X / 17734583). IT WAS REPORTED THAT THE COIL ENCOUNTERED A LOT OF RESISTANCE DURING THE ATTEMPT TO ADVANCE IT IN THE MICROCATHETER; IT WAS IMPEDED IN THE MICROCATHETER AND IT HAD TO BE REMOVED. THE DELIVERY WIRE BECAME BROKEN WHILE THE COIL WAS STILL INSIDE THE MICROCATHETER. AS A RESULT, BOTH THE COIL AND THE MICROCATHETER WERE REMOVED AND AS A RESULT, THE CEREBRAL TARGET POSITION OF THE MICROCATHETER WAS LOST. IT WAS CONFIRMED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE EVENT DID NOT RESULT IN ANY INTERRUPTION OF BLOOD FLOW. THE REPORTED EVENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATION; THE PROCEDURAL DELAY WAS APPROXIMATELY 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611118 ↗
• MalfunctionMay 31, 2018Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A SUPRACLINOID INTERNAL CAROTID ARTERY (ICA ANEURYSM, STRONG RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE 4X12 ORBIT GALAXY TDL COMPLEX FILL (640CF0412/17482867) HYDRAULIC COIL THROUGH THE MIDSHAFT OF THE PROWLER SELECT LPES MICROCATHETER (606S155X/17734584). THE COIL GOT STUCK AND COULD NO LONGER ADVANCE. UPON REMOVAL, THE COIL WAS DETACHED IN THE MIDSHAFT OF THE MICROCATHETER, BEFORE THE PROXIMAL MARKER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EMBOLIC COIL PREMATURELY DETACHED IN THE MICROCATHETER. IT WAS STATED THAT ¿THE COIL GOT BREAK IN THE MIDSHAFT OF MICROCATHETER IT WAS UNABLE TO PUSH FURTHER SO WHEN WE TRIED TO PULL THE DELIVERY WIRE DETACHED COIL WAS NOT MOVING AT ALL¿. THE DIFFICULTY REQUIRED THAT THE COIL AND MICROCATHETER BE REMOVED TOGETHER AS A UNIT. THE COIL AND MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE EVENT. THE COMPLAINT COIL WAS THE FIRST COIL USED IN THE CASE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556242 ↗
• MalfunctionJan 24, 2018Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A CAROTID CAVERNOUS FISTULA FROM THE VENOUS SIDE, THE DISTAL ACCESS OF COIL# 8, A 5 X 15 GALAXY FILL COIL (GLY120515 L10144), BECAME ¿JAMMED¿ IN THE DISTAL TIP OF THE PROWLER SELECT LPES MICROCATHETER (606S155X/17680651). THE COIL COULD NOT BE PUSHED FORWARD NOR PULLED BACK. APPROXIMATELY 3 MM OF THE COIL HAD EXITED THE DISTAL TIP OF THE MICROCATHETER, BUT DID RESULT IN REDUCTION OF BLOOD FLOW OR PATIENT INJURY. THE PROCEDURE WAS DELAY 15 MINUTES DUE TO THE EVENT. THE COIL WAS REMOVED WITH THE MICROCATHETER WITHOUT INCIDENT AND THE PHYSICIAN REPORTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. ACCESS WAS REGAINED WITH AN ECHELON 10 MICROCATHETER AND COILING WAS CONTINUED WITHOUT INCIDENT WITH A PACKING DENSITY OF 52%. DEVICES HAD BEEN PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU) AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED. THE MICROCATHETER TIP HAD NOT BEEN RE-SHAPED AND THE MICROCATHETER DID NOT APPEAR KINKED OR DAMAGED IN ANY WAY. THERE WAS NO EVIDENCE OF DAMAGE TO THE ACTUAL COIL. THE COIL WAS STILL ATTACHED TO THE DELIVERY WIRE WHEN REMOVED FROM THE PATIENT. PATIENT INFORMATION WAS NOT AVAILABL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216205 ↗
• MalfunctionJul 5, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BASILAR ARTERY ANEURYSM COILING, A GALAXY G2 COIL (641CF0412/S12782) COULD NOT BE PUSHED IN THE PROWLER LPES MICROCATHETER (606S155X/17161634). THE COIL WAS REMOVED WITH THE MICROCATHETER. THE G2 DID NOT APPEAR DAMAGED. THERE WAS NO PATIENT INJURY OR SIGNIFICANT DELAY IN THE PROCEDURE. THEY COMPLETED THE PROCEDURE WITH ANOTHER MICROCATHETER AND COIL. IT WAS REPORTED THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687112 ↗

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