PROWLER SELECT 606-S255XRecalls & reported problems

Summary

The FDA's MAUDE database contains 980 adverse event reports that list this exact device (DI 10886704028888), received between Sep 23, 2016 and Sep 30, 2026 — classified as 2 deaths, 22 injuries, 956 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (943 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 980 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947908 ↗
• MalfunctionSep 29, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933872 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873094 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872982 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871933 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869694 ↗
• MalfunctionSep 15, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776614 ↗
• MalfunctionSep 15, 2026Difficult to Advance; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776611 ↗
• MalfunctionSep 11, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736667 ↗
• MalfunctionSep 10, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714216 ↗
• MalfunctionSep 9, 2026Physical Resistance/Sticking

  The healthcare professional reported that during a thrombectomy procedure targeting a right middle cerebral artery occlusion, the 150cm x 5cm Prowler Select Plus microcatheter (606S255X / 31815458) was in place and the stent (unspecified brand) was impeded in the proximal end of the microcatheter and could not advance further. The physician removed the stent and the microcatheter from the patient and replaced the microcatheter to deliver the original stent to complete the procedure, which was prolonged by about 10 minutes. There was no report of any negative patient impact.On 03-Sep-2026, additional information was received. The information confirmed that the thrombectomy procedure was targeting a right middle cerebral artery occlusion. A continuous flush was maintained through the microcatheter. There was no damage noted on the microcatheter that may have caused the stent to become obstructed. The replacement microcatheter was another 150cm x 5cm Prowler Select Plus microcatheter (606S255X). The information also confirmed there was no negative impact to the patient and no delay to the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695008 ↗
• MalfunctionSep 9, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694169 ↗
• MalfunctionSep 1, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548776 ↗
• MalfunctionAug 31, 2026Physical Resistance/Sticking

  A healthcare professional reported that during an endovascular embolization, when delivering a 4.5MMD 22MML ENTERPRISE Vascular Reconstruction Device (product code: ENC452200, lot number: 9682206), the stent became impeded in the distal end of a PROWLER SELECT PLUS 150/5CM Microcatheter (product code: 606S255X, lot number: 31874892) and could not pass through the microcatheter (MC). The doctor removed the stent and microcatheter from the patient and then sequentially switched to a second microcatheter, aPROWLER SELECT PLUS 150/5CM (product code: 606S255X, lot number: 31519699) to deliver the original stent. The original stent was still impeded in the distal end of the second and third microcatheter and could not pass through the second and the third microcatheter. Finally, the doctor only retracted the original stent alone and switched to a second stent to complete the surgery. The third microcatheter was not replaced. The surgery was prolonged by about 15 minutes. Does surgeon have an extra set of hands to support while flushing aligning the Enterprise system was answered as ¿yes¿. Is a push plunge RHV being used was answered as ¿twisted type¿. Is there force needed to remove the

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524645 ↗
• MalfunctionAug 27, 2026Physical Resistance/Sticking

  The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 23mm Enterprise 2 (ENCR402312 / 10071618) was impeded in the distal end of the associated 150cm x 5cm Prowler Select Plus microcatheter (606S255X / 31877599) and could not pass through the microcatheter. The physician removed the stent, which was still inside the microcatheter, and the microcatheter from the patient and replaced both devices with devices from different manufacturers to complete the procedure. There was no report of any negative patient impact.On (b)(6) 2026, additional information was received. Per the information, the procedure was targeting the middle cerebral artery (MCA). The information indicated that there was resistance during the advancement of the stent; the stent was impeded in the distal end of the microcatheter during the procedure. Continuous flush was maintained through the microcatheter. The flush was heparinized saline. There was no damage noted on the microcatheter. There was no negative patient impact and no delay to the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50487258 ↗
• MalfunctionAug 19, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328755 ↗
• MalfunctionAug 19, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325764 ↗
• MalfunctionAug 17, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280836 ↗
• MalfunctionAug 14, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255513 ↗
• MalfunctionAug 5, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146678 ↗
• MalfunctionAug 5, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146648 ↗
• MalfunctionJul 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058811 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036632 ↗
• MalfunctionJul 1, 2026Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 37MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC453700, LOT NUMBER: 10021148) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. DOES SURGEON HAVE AN EXTRA SET OF HANDS TO SUPPORT WHILE FLUSHING ALIGNING THE ENTERPRISE SYSTEM WAS ANSWERED AS ¿YES¿. IS A PUSH PLUNGE RHV BEING USED WAS ANSWERED AS ¿TWISTED TYPE¿. IS THERE FORCE NEEDED TO REMOVE THE DELIVERY WIRE ONCE IMPEDED AND THEN THE STENT DETACHES IN THE HUB OR THE PROXIMAL END OF THE MICROCATHETER WAS ANSWERED AS ¿NOT APPLICABLE¿. THE STENT WAS DETACHED FROM THE DELIVERY WIRE DURING ITS DELIVERY IN THE MICROCATHETER. THE REPLACEMENT STENT WAS AN ENTERPRISE1 OF THE SAME PRODUCT CODE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679028 ↗
• MalfunctionJul 1, 2026Physical Resistance/Sticking

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE EU ENT4.5MMD 28MML WNO DSTL TP VASCULAR RECONSTRUCTION DEVICE (ENC452800/ 9651821) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THAT THE STENT WAS INTENTIONALLY DEPLOYED AND DETACHED; HOWEVER, THE STENT WAS NOT IN THE DESIRED POSITION, BUT IT STILL COVERED THE ANEURYSM NECK COMPLETELY. DOCTOR PLANNED TO RELEASE A SECOND STENT, AN ENTERPRISE EU ENT4.5MMD 22MML WNO DSTL TP VASCULAR RECONSTRUCTION DEVICE (ENC452200/ 9730959), TO ACHIEVE A BETTER EFFECT, SO DELIVERED A SECOND STENT. THE SECOND STENT WAS IMPEDED IN THE MICROCATHETER HUB AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND MICROCATHETER FROM THE PATIENT AND GAVE UP IMPLANTING THE SECOND STENT, THEN COMPLETED THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. NO PATIENT HARM WAS REPORTED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿INACCURATE PLACEMENT & IMPEDED IN MICROCATHETER-MICROCATHETER HUB. IT WAS REPORTED THAT DURING PROCEDURE, STENT WAS ADVANCED TO THE TARGET SITE AND WAS STARTED TO RELEASE. THE STENT WAS NOT DEPLOYED IN THE DESIRED POSITION, BUT IT STILL COVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678639 ↗

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.