Corsair Pro CSR135-26PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327111843), received between Apr 27, 2017 and Aug 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL TO MID SEGMENT OF THE RIGHT CORONARY ARTERY (RCA) WAS CROSSED WITH AN UNSPECIFIED GUIDE WIRE AND THE SUBJECT ASAHI CORSAIR PRO MICROCATHETER BY ACCESSING FROM THE RADIAL ARTERY. AFTER THE GUIDE WIRE WAS EXCHANGED FOR A ROTAWIRE FLOPPY GUIDE WIRE (BOSTON SCIENTIFIC), THE CORSAIR PRO MICROCATHETER GOT RUPTURED AND DETACHED IN THE CORONARY ARTERY WHEN AN ATTEMPT WAS MADE TO REMOVE THE MICROCATHETER ALONG THE ROTAWIRE FLOPPY GUIDE WIRE THAT HAD BEEN INSERTED INSIDE THE DEVICE. ALL OF THE FRAGMENTS WERE REMOVED AND THE ROTAWIRE FLOPPY GUIDE WIRE WAS REMOVED INTACT. IT WAS INFORMED THAT THERE WAS NO HEALTH HAZARDS OR COMPLICATION OCCURRED TO THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903853 ↗
• InjuryJan 15, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A CORONARY CTO OF THE DISTAL CIRCUMFLEX ARTERY, A LESION CAP WAS ENGAGED WITH THE WIRE AND PASSED WITH SOME EFFORT. THE SUBJECT MICROCATHETER WAS ADVANCED OVER THE CONCOMITANT GUIDE WIRE TO THE CAP WHERE IT WAS USED IN THE NORMAL FASHION. OVER THE COURSE OF TRYING TO CROSS THE LESION, THE PHYSICIAN NOTICED THAT THE SUBJECT MICROCATHETER WAS DRAGGING ON THE WIRE; AN ATTEMPT TO WITHDRAW IT WAS UNSUCCESSFUL. IT WAS DETERMINED THAT BOTH OF THE MICROCATHETER AND GUIDE WIRE WERE REMOVED AS A UNIT. UPON REMOVAL OF THE SYSTEM, AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE OUT OF THE SUBJECT MICROCATHETER, BUT IT WAS UNSUCCESSFUL. A SECOND CATHETER AND A GUIDE WIRE WERE USED BUT DUE TO THE SEVERITY OF THE LESION, THE LESION COULD NOT BE CROSSED. THE DYE COUNT WAS REACHING THE AMOUNT WHERE THE CASE HAD TO BE STOPPED. NO ILL EFFECTS WERE OBSERVED AND A DECISION WILL BE MADE TO SEE IF THE PATIENT WILL BE BROUGHT BACK LATER. THE PATIENT WAS DISCHARGED AFTER NORMAL RECOVERY TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7190084 ↗
• InjuryApr 27, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING PCI TO TREAT A MODERATELY CALCIFIED CTO LESION, AN ASAHI CATHETER WAS ADVANCED TO THE SEPTAL COLLATERAL VESSEL. WHEN THE PHYSICIAN SPUN THE CATHETER AND PULLED BACK, THE CATHETER TIP SEPARATED FROM THE CATHETER SHAFT. ALTHOUGH ATTEMPTED, RETRIEVAL OF THE TIP FRAGMENT FAILED AND THE PHYSICIAN DECIDED TO TREAT THE PATIENT MEDICALLY. THE PHYSICIAN DESCRIBED THE ANATOMY AS "HOSTILE". THE PATIENT HAD BEEN FINE WITH NO HEALTH IMPACTS.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 6528707 ↗