PROWLER SELECT 606-S272XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704028895), received between Oct 1, 2019 and Jun 30, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 60-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CONGESTIVE HEART FAILURE AND HYPERTENSION PRESENTED WITH AN UNWITNESSED, NON-WAKE-UP STROKE ON (B)(6) 2023. SHE WAS LAST SEEN WELL THE DAY BEFORE, ON (B)(6) 2023. THE PATIENT PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGINAL OF THE EMBOLISM DOCUMENTED IN THE CASE REPORT FORM (CRF) IS OF ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE A NIH STROKE SCALE (NIHSS) SCORE WAS 16 AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY. A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET307522 / 22L259AV) WAS USED WITH A 170CM X 15CM 2 MARKERS PROWLER SELECT PLUS MICROCATHETER (606S272X / 30561949), A FLOWGATE2¿ BALLOON GUIDE CATHETER (STRYKER), AND AN AXS CATALYST® 6 DISTAL ACCESS CATHETER (STRYKER). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS TARGETING AN OCCLUSION AT THE TERMINAL BIFURCATION OF THE LEFT INTERNAL CAROTID ARTERY (ICA) ¿ ¿CAROTID

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17241111 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, AT THE END OF THE PROCEDURE, A PROWLER SELECT PLUS 170/15 CM MICROCATHETER ( 606S272X, 30858782) SHOWED A GEL-LIKE SUBSTANCE AT THE PROXIMAL END OF THE HEMOSTATIC VALVE. THERE WAS NO PATIENT INJURY REPORTED. IN ORDER TO FURTHER INVESTIGATE THIS MATTER, THE CUSTOMER HAD THE PROWLER SELECT PLUS MICROCATHETER, THE ASSOCIATED HEMOSTATIC VALVES, AND A BRAND-NEW CATHETER EXAMINED IN A SUITABLE INSTITUTE. ADDITIONAL INFORMATION RECEIVED OF THE DEVICE INVOLVED CONCLUDED THE FOLLOWING: THE FT-IR SPECTRA OF THE DRYING RESIDUES OF THE CLOUDY APPEARING LIQUIDS AT THE END OF THE VALVE OF THE USED MICRO CATHETER SHOW A SIGNIFICANT ACCORDANCE TO THE SPECTRUM OF THE OUTER SURFACE OF THE DISTAL END AS WELL AS THE ONE OF THE OUTER SURFACE OF THE LIGHT BLUE COLOURED PART OF THE UNUSED CATHETER (P1). THE SPECTRA ALSO SHOW A SIGNIFICANT ACCORDANCE TO DATABASE SPECTRA OF POLYVINYLPYRROLIDONE. THE RESIDUES IN THE SAMPLE PROBABLY CONSIST OF POLYVINYLPYRROLIDONE. THE FT-IR SPECTRUM OF THE WHITISH PARTICLE IN THE LIQUID AT THE END OF THE VALVE OF THE SAMPLE SHOWS A VERY HIGH ACCORDANCE TO DATABASE SPECTRA OF DIFFERENT PROTEINS. THE PARTICLE IS VERY LIKELY FORMED BY PROTEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629159 ↗
• MalfunctionSep 8, 2020Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY OF THE LEFT CEREBRAL MEDIA ARTERY, THE INNER LINER OF A 170/15 CM PROWLER SELECT PLUS (606S272X, UNKNOWN LOT) WAS ¿RUBBED OFF¿ AFTER TWO MANEUVERS WITH STENT RETRIEVERS (FIRST, EMBOTRAP 2 5X33MM AND SECOND, SOLITAIRE X 4X40MM). THE MICROCATHETER WAS REPLACED, NOT BY A PROWLER SELECT PLUS. THE SURGERY WAS DELAYED BY THREE MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO PERFORMANCE ISSUES WITH THE EMBOTRAP. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS RESISTANCE BETWEEN THE MICROCATHETER AND THE STENT RETRIEVERS AFTER THE INNER LINER WAS GONE. THE FRICTION BETWEEN THE STENT RETRIEVER AND THE MICROCATHETER INCREASED. THAT WAS THE CAUSE OF THE MICROCATHETER BEING REPLACED. THERE WAS NO REPORT OF ANY COATING FLAKES ENDING UP IN THE PATIENT. ADDITIONAL INTERVENTION WAS NOT NEEDED TO REMOVE THE DEVICE FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10503583 ↗
• MalfunctionOct 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY IT WAS NOT POSSIBLE TO INSERT A 5X33 EMBOTRAP 2 (ET007533, 18M017AV) INTO A 170CM PROWLER SELECT PLUS MICROCATHETER (606S272X, 30066730). INSTEAD OF SMOOTH INSERTION AS USUAL THE EMBOTRAP 2 WAS DESTROYED DURING ATTEMPT. A MEDTRONIC SOLITAIRE MICROCATHETER (MC) WAS USED INSTEAD BUT PROBLEM WAS PERSISTENT, AND THE SOLITAIRE MC WAS ALSO DESTROYED. A NEW (170CM) PROWLER SELECT PLUS (606S272X, 30066730) WAS USED AND PLACED IN THE TARGET VESSEL. A SECOND 5X33 EMBOTRAP 2 (ET007533, 18M017AV) WAS DESTROYED DUE TO THE SAME PROBLEM. EVENTUALLY IT WAS WITH DIFFICULTIES THAT IT WAS POSSIBLE TO INSERT A PRESET (PHENOX) THROMBECTOMY DEVICE INTO THE PROWLER SELECT PLUS. THE PROCEDURE WAS FINISHED WITH THIS SETUP. THERE WAS A SURGERY DELAYED OF 30 MINUTES DUE TO THE REPORTED EVENTS. IT IS UNKNOW IF THE PATIENT¿S CONDITION WORSENED AS A RESULT OF THE SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9140871 ↗

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.