PROWLER SELECT 606-S252Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704028819), received between Oct 18, 2016 and Jun 10, 2019 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿DISSECTING INTERNAL CAROTID ANEURYSM CAUSING EPISTAXIS : A CASE REPORT.¿ AN (B)(6) WOMAN EXPERIENCED EPISTAXIS AND SUFFERED FROM HEMORRHAGIC SHOCK AT HER PREVIOUS HOSPITAL. HEAD COMPUTED TOMOGRAPHY (CT) IMAGES REVEALED A RUPTURED INTERNAL CAROTID ANEURYSM PROTRUDING INTO THE ONODI CELL, THE MOST POSTERIOR ETHMOIDAL SINUS, WHICH EXTENDS SUPEROLATERALLY TO THE SPHENOID SINUS. CEREBRAL ANGIOGRAPHY DEMONSTRATED A MULTILOBULAR-SHAPED DISSECTING ANEURYSM WITH A MAXIMAL DIAMETER OF 6.7 MM AT THE CAVERNOUS PORTION OF THE INTERNAL CAROTID ARTERY (ICA). OVERLAPPING STENTING WAS PERFORMED TO PREVENT RECANALIZATION. HOWEVER, A FATAL SUBARACHNOID HEMORRHAGE OCCURRED 2 DAYS AFTER THE PROCEDURE DUE TO THE PROGRESSION OF THE DISSECTION TO THE INTRACRANIAL. THE ANATOMICAL CHARACTERISTICS OF THE ETHMOIDAL SINUS COULD BE ASSOCIATED WITH THE OCCURRENCE OF EPISTAXIS.

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 8683656 ↗
• MalfunctionDec 17, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A CHRONIC SUBDURAL HEMATOMA AT THE MIDDLE MENINGEAL ARTERY (MMA), THE PROWLER SELECT PLUS 150/15CM (606S252/17399222) MICROCATHETER WAS DELIVERED TO THE TARGET LESION AND A TORNADO 18 (COOK MEDICAL) EMBOLIZATION COIL WAS ADVANCED, BUT THE COIL BECAME STUCK INSIDE THE MICROCATHETER. THE MICROCATHETER WAS WITHDRAWN FROM THE VESSEL AND FLUSHED WITH A SYRINGE IN AN EFFORT TO REMOVE THE COIL FROM THE INNER LUMEN. HOWEVER, THE COIL WOULD NOT EXIT THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REPLACED WITH A COMPETITOR DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A MEDIKIT SHEATH INTRODUCER, A 6F FUBUKI (ASAHI INTECC) GUIDING CATHETER, A TRAXCESS (TERUMO) GUIDEWIRE, AND A Y-CONNECTOR (GOODMAN) WERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171317 ↗
• MalfunctionDec 11, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR AN ACUTE ISCHEMIC STROKE, A COIL (UNKNOWN BRAND) WAS INSERTED INTO THE 150CM X 15CM PROWLER SELECT PLUS MICROCATHETER (606S252 / 17381139) AND RESISTANCE WAS FELT BETWEEN THE MICROCATHETER AND THE COIL. THE MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR 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) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153675 ↗
• MalfunctionDec 6, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ISSUE RELATED TO THE PROWLER SELECT PLUS, 150CM X 15CM, 1 MARKER (606S252/17381139) OCCURRED DURING THE COIL EMBOLIZATION PROCEDURE OF AN ACUTE STAGE BRAIN INFARCTION AT THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE THROMBUS REMOVAL STEP OF THE PROCEDURE, THE PROWLER SELECT PLUS MICROCATHETER WAS USED WITH A GUIDEWIRE (CHIKAI, ASAHI INTECC) WHEN RESISTANCE WAS FELT WITH THE GUIDEWIRE. THE PROWLER SELECT PLUS WAS CONFIRMED TO BE PARTIALLY CRUSHED IN THE BODY/SHAFT OF THE MICROCATHETER. THE RESISTANCE EXPERIENCED WITH THE GUIDEWIRE WAS A RESULT OF THE PARTIALLY OBSTRUCTED/CRUSHED PORTION ON THE MICROCATHETER. THE MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR 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) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THE PROWLER SELECT PLUS MICROCATHETER IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139805 ↗
• MalfunctionNov 22, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF A BASILAR APEX ANEURYSM, THE PHYSICIAN HAD DIFFICULTY POSITIONING THE PULSERIDER (201D/W308607), AND DURING REMOVAL, IT DID NOT PULL BACK INTO THE 021¿ PROWLER SELECT PLUS MICROCATHETER (606S252/ 17676317) AND BOTH DEVICES WERE REMOVED. THE NECK WIDTH WAS 7.92MM, PARENT VESSEL DIAMETER WAS 3.04MM, AND IMPLANT ARCH WIDTH WAS 10 T. THE PROWLER SELECT PLUS HAD BEEN ADVANCED THROUGH THE 5F CHAPEREON 90CM GUIDE CATHETER INTO THE RIGHT VERTEBRAL ARTERY AND THE PULSERIDER WAS POSITIONED INTO THE BASILAR ARTERY AT THE NECK OF THE ANEURYSM. THE DEVICE WAS RE-POSITIONED AND PULLED BACK INTO THE PROWLER SELECT PLUS TWICE. THE DECISION WAS MADE TO REMOVE THE DEVICE AND USE ANOTHER PULSERIDER SHAPE; HOWEVER, THE PHYSICIAN HAD TROUBLE PULLING THE DEVICE BACK INTO THE CATHETER ENTIRELY. THE PULSERIDER AND MICROCATHETER WERE BOTH REMOVED WITHOUT INCIDENT OR NEED FOR INTERVENTION. THE TARGET VESSEL WAS MODERATELY TORTUOUS. THE DEVICES HAD BEEN PREPPED AND USED AS PER THE INSTRUCTION FOR USE (IFU). THERE HAD BEEN NO RESISTANCE BETWEEN THE PULSERIDER AND PROWLER DURING ADVANCEMENT AND THE DEVICE HAD NOT BEEN TORQUED AGAINST RESISTANCE. A C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052693 ↗
• MalfunctionSep 15, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING CO9IL EMBOLIZATION OF AN M1 CEREBRAL ANEURYSM, A REVIVE SE COULD NOT ADVANCE THROUGH A PROWLER SELECT PLUS MICROCATHETER (606S252/ 17381139). THE PHYSICIAN HAD ATTEMPTED TO INSERT THE REVIVE SE, BUT THERE WAS RESISTANCE FELT AND IT COULD NOT BE DELIVERED. THE CATHETER WAS REPLACED WITH ANOTHER ONE (MARKSMAN), AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 3 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 THE EVENT. THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6869352 ↗
• MalfunctionJan 13, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH PROWLER SELECT PLUS (606S252/17379147) CATHETER. THE PROCEDURE WAS FOR TREATMENT OF ACUTE ISCHEMIC STROKE AT THE INTERNAL CAROTID ARTERY. THE PATIENT WAS MALE WHOSE VESSELS WERE MODERATELY TORTUROUS AND MODERATELY CALCIFIED. THE LESION WAS THE M2. AFTER CROSSING WITH THE COMPLAINT PROWLER SELECT PLUS, A REVIVE WAS DELIVERED. HOWEVER THERE WAS RESISTANCE FELT WITH THE COMPLAINT PROWLER SELECT PLUS. THEREFORE IT WAS REPLACED WITH A NEW MICRO CATHETER (NON-CODMAN). THE PHYSICIAN REPORTED THAT THE SAME INCIDENT OCCURRED TWICE IN A ROW, AND SEEMED TO BE GETTING DOUBTFUL WITH PROWLER SELECT PLUS. 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 AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6248937 ↗
• MalfunctionOct 18, 2016Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR ALTERATION OF BLOOD FLOW, A PUSHABLE COIL FELT RESISTANCE AT THE HUB OF A PROWLER SELECT PLUS (606S252/17379147), AND THE UNSPECIFIED PUSHABLE COIL COULD NOT BE ADVANCED. THE PROWLER SELECT PLUS WAS REPLACED WITH ANOTHER MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6037991 ↗

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.