Corsair Pro CSR150-26PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327111850), received between Dec 20, 2018 and Apr 27, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO HAD DETACHED DURING AN UNSPECIFIED PERCUTANEOUS INTERVENTION TO TREAT AN UNSPECIFIED LESION. THE PHYSICIAN WAS ATTEMPTING TO CROSS THE LESION WITH THE CORSAIR PRO MICROCATHETER BUT WAS UNSUCCESSFUL. AFTER REMOVING THE CATHETER FROM THE BODY OVER THE WIRE, HE NOTED THE TIP TO BE SHREDDED. NO FRAGMENTS NOTED TO BE WITHIN THE PATIENT OR ACCESS SITE ACCORDING TO THE PHYSICIAN. THE PATIENT SUSTAINED NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16821400 ↗
• MalfunctionApr 21, 2023Fracture; Fracture

  DR. WAS ATTEMPTING TO CROSS LESION WITH CORSAIR PRO MICROCATHETER BUT WAS UNSUCCESSFUL. AFTER REMOVING THE CATHETER FROM THE BODY OVER THE WIRE HE NOTED THE TIP TO BE SHREDDED. NO FRAGMENTS NOTED TO BE WITHIN THE PATIENT OR ACCESS SITE ACCORDING TO DR. WAS SAVED TO BE RETURNED FOR INSPECTION. PATIENT SUSTAINED NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792359 ↗
• InjuryDec 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO MICROCATHETER BECAME SEPARATED DURING AN INTERVENTION TO TREAT A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL TIBIAL ARTERY. PEDAL ACCESS WAS CHOSEN. IT WAS UNABLE TO ADVANCE PRIMARY GUIDEWIRE (ASAHI PROWATER) , SO CORSAIR PRO WAS ADVANCED OVER-THE-WIRE TO FACILITATE. WHEN THE CATHETER WAS ADVANCED THERE WAS MODERATE RESISTANCE CONSISTENT WITH HEAVILY CALCIFIC BURDENED PERIPHERAL VASCULAR DISEASE AND REQUIRED SOME EXTRA FORCE TO ADVANCE. THE MICROCATHETER WAS TORQUED X3 ROTATIONS AND PRIMARY OPERATOR NOTED THAT TIP WAS SEPARATED FROM THE DEVICE. THE MICROCATHETER WAS REMOVED FROM THE BODY AND A SNARE WAS ADVANCED TO RETRIEVE THE TIP OF THE CATHETER. NO PATIENT SEQUELAE NOTED. NO RETAINMENT OF ANY PART OF THE DEVICE. THE PROCEDURE COMPLETED SUCCESSFULLY AFTER CONVERSION TO NON-ASAHI TURNPIKE SPIRAL AND MORE AGGRESSIVE WIRE (ASAHI ASTATO 40). THE PATIENT WAS DISCHARGED SAME DAY WITHOUT SEQUELA. THE PHYSICIAN STATED DEVICE DRIVEN INTO THE PROXIMAL CAP BEFORE TORQUING. BY THEIR OWN ADMISSION, THE MICROCATHETER WAS TORQUED WHEN THE TIP WAS LIKELY WEDGED IN THE PLAQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085763 ↗
• MalfunctionDec 17, 2021Break

  BTK CTO CASE WITH NOTED CA++. UNABLE TO ADVANCE PRIMARY GUIDEWIRE (PROWATER) , SO CORSAIR PRO (CP) ADVANCED OTW TO FACILITATE. CP TORQUED X3 ROTATIONS AND PRIMARY OPERATOR NOTED THAT TIP WAS SEPARATED FROM DEVICE. CP REMOVED FROM BODY AND SNARE ADVANCED TO RETRIEVE TIP OF CATHETER. NO PT SEQUELAE NOTED. NO RETAINMENT OF ANY PART OF DEVICE. PROCEDURE COMPLETED SUCCESSFULLY AFTER CONVERSION TO TURNPIKE SPIRAL AND MORE AGGRESSIVE WIRE (B)(4). PT DISCHARGED SAME DAY. PHYSICIAN STATED DEVICE DRIVEN INTO PROXIMAL CAP BEFORE TORQUING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026606 ↗
• InjuryDec 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A CORSAIR PRO CATHETER BECAME SEPARATED DURING A PCI. 8FR LONG FEMORAL SHEATHS WERE PLACED IN BILATERAL, 8FR AL .75 GUIDE WAS PLACED IN THE RCA, AND 8FR EBU 3.5 WAS PLACED IN THE LAD. THE RCA WAS WIRED WITH A PILOT 200 GUIDE WIRE FOLLOWED BY THE CORSAIR PRO. THE CORSAIR PRO WAS ADVANCED TWISTING AS PER IFU. AT MID TO DISTAL SECTION OF THE RCA WHILE TWISTING THE DISTAL RADIOPAQUE END OF THE CORSAIR PRO BROKE OFF FROM THE REST OF THE CORSAIR PRO. ATTEMPTS WERE MADE WITH BALLOONS TO PRE-DILATE THE RCA TO ADVANCE A SNARE DOWN. UNFORTUNATELY NEITHER THE BALLOONS NOR THE SNARE WERE ABLE TO ADVANCE TO THE DISLODGED CORSAIR PRO TIP. WHILE TRYING TO SNARE, THE SNARE KINKED THE PILOT 200 CAUSING LOSS OF PLACEMENT OF THE WIRE. ANTEGRADE ABORTED AND ATTEMPTED TO GO RETROGRADE, HOWEVER, FAILED AS THERE WERE NO COLLATERAL OPTIONS. THE SEPARATED TIP WAS LEFT IN SITU. THE PATIENT WAS FINE WITHOUT INJURY OR COMPLICATION.

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

  MAUDE report 8183443 ↗