Corsair CSW135-26NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327087964), received between Aug 3, 2017 and Apr 24, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI MICROCATHETER BECAME SEPARATED DURING A PCI TO TREAT A HEAVILY CALCIFIED CTO IN THE LAD. THE PATIENT WAS HAVING DIALYSIS TREATMENT IN OTHER CLINIC WHEN HE WENT IN TO ARREST AT WHICH POINT HE WAS TRANSFERRED TO THE HOSPITAL. THE PATIENT WAS SHOCKED AT LEAST ONCE AND RESUMED RHYTHM PRIOR TO THE PCI. ANGIOGRAM WAS DONE WHICH IDENTIFIED MULTI VESSEL DISEASE: LARGE LEFT MAIN, 90% PROXIMAL LAD, MID LAD CTO, DISTAL LAD DISEASE, HEAVILY COLLATERALIZED, CTO OF PROXIMAL CIRCUMFLEX, AND EDP OF 15. A 6FR GUIDE CATHETER WAS PLACED IN THE LAD, FOLLOWED BY SUCCESSFUL PLACEMENT OF A NON-ASAHI STENT IN MID LAD. THEN THE DISTAL LAD CTO WAS WIRED WITH AN ASAHI GUIDE WIRE WHICH CROSSED LESION AND THEN THE SUBJECT MICROCATHETER WAS ADVANCED TO PROXIMAL CAP OF DISTAL LAD LESION AS WAS BEING ROTATED WHEN ITS TIP BECAME DISLODGED AND REMAINED EMBEDDED IN THE LESION AFTER WIRE WAS REMOVED. NO REMEDIAL ACTION WAS TAKEN AGAINST THE SEPARATED TIP. THE PATIENT WAS TRANSFERRED TO ICU AND STABLE AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 IN A REHAB FACILITY.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 7453407 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH A LARGE ANEURYSM IN A 99 TO 100% OCCLUDED, HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A NON-ASAHI GUIDE WIRE WAS ADVANCED VIA RIGHT COMMON FEMORAL ARTERY ACCESS INTO A NON-ASAHI GUIDING CATHETER AND CROSSED THE ANEURYSM INTO THE POSTERIOR DESCENDING CORONARY ARTERY WITH DIFFICULTY DUE TO PATIENT ANATOMY. AN ATTEMPT WAS THEN MADE TO EXCHANGE THE GUIDE WIRE FOR A NON-ASAHI ATHERECTOMY WIRE, BUT THESE WIRES WERE UNABLE TO BE EXCHANGED, DESPITE ADVANCEMENT ASSISTANCE ATTEMPTED WITH THE SUBJECT MICROCATHETER, A 1.25 X 12 MM NON-ASAHI BALLOON CATHETER, AND A NON-ASAHI SPIRAL CATHETER. THE NON-ASAHI GUIDE WIRE WAS, THUS, PULLED BACK TO A LESS OCCLUDED VESSEL AREA TO FACILITATE ADVANCEMENT OF ANOTHER NON-ASAHI GUIDE WIRE, THEN A ASAHI GUIDE WIRE, USING THE SPIRAL CATHETER FOR ADVANCEMENT SUPPORT, BUT, AFTER ATTEMPTING TO CROSS FOR AN HOUR, THESE GUIDE WIRES WERE UNABLE TO CROSS THE LESION. THE LESION WAS RE-WIRED USING A NOON-ASAHI GUIDE WIRE, FOLLOWED BY ADVANCEMENT OF THE SPIRAL CATHETER. PRE-DILATATION, ATHERECTOMY, ADDITIONAL PRE-DILATATION, THEN STENTING OF THE DISTAL RCA WITH A 3.5 X 30 MM STENT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762702 ↗