Crosser iQ XCTO146Recalls & reported problems
Bard Peripheral Vascular, Inc. · Crosser iQ Ultrasonic CTO Device · Class 2
Quick summary
This Bard Crosser iQ catheter is an ultrasonic device used to open fully blocked arteries. Its 154 reports mostly describe parts separating, such as tips or marker bands detaching, and core wires stretching. The reports include no deaths and 9 injuries, and 145 are malfunctions. No recalls name this device. Reports rose from 50 in the year before to 81 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00801741201332), received between Feb 25, 2022 and Sep 29, 2026 — classified as 10 injuries, 147 malfunctions.
The most frequently reported specific device problem is “Material Separation” (90 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation90
- Detachment of Device or Device Component50
- Device-Device Incompatibility28
- Material Deformation24
- Failure to Advance15
- Peeled/Delaminated14
- Material Split, Cut or Torn13
- Retraction Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions147
- Foreign Body In Patient8
- Perforation of Vessels3
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Advance; Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent a recanalization procedure using the Crosser iQ catheter for treatment of a calcified lesion. During the procedure, approximately four minutes into use, it became difficult to cross the lesion. Upon pulling the device back, the tip of the device detached. As the patient is not fit for open surgery at that stage, the tip remained embedded in the calcified vessel. The procedure was not completed. The surgeon is following up with the patient for another surgery. The patient was later discharged.
Patient problems: Foreign Body In Patient
MAUDE report 50928868 ↗MalfunctionSep 28, 2026Material Separation
On (b)(6) 2026, a patient underwent a recanalization procedure using the Crosser catheter. During the procedure, damage and misalignment of the catheter tip relative to the shaft were observed. The tip remained attached to the catheter and was removed with the device. The procedure was completed using another catheter. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911164 ↗MalfunctionSep 15, 2026Material Separation
On (b)(6) 2026, a patient underwent a recanalization procedure via contralateral approach using the catheter. During the procedure, material separation was observed at the catheter tip approximately 5 minutes of use but was still attached to the corewire. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770848 ↗MalfunctionSep 10, 2026Material Separation
On (b)(6) 2026, a patient underwent a recanalization procedure using a Crosser iQ catheter for the treatment of popliteal artery calcification via an ipsilateral antegrade approach. During the procedure, it was reported that the healthcare professional flushed the catheter for approximately 20 seconds, after which the catheter tip detached. It was further reported that the tip remained attached to the core wire. The procedure was subsequently completed using another Crosser iQ catheter. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707610 ↗MalfunctionSep 10, 2026Material Separation
On (b)(6) 2026, a patient underwent a recanalization procedure using a Crosser iQ catheter for the treatment of a highly calcified popliteal lesion. During the procedure, just before reaching the lesion, the guidewire was retracted approximately 1 cm into the catheter, and the device was activated. While advancing through the highly calcified popliteal lesion in the presence of vessel tortuosity, difficulty with device tracking was encountered. After approximately 4 minutes of operation, an abnormality was observed under fluoroscopy. A fracture was identified in the core wire connected to the titanium tip, and the device was immediately withdrawn. It was further reported that the titanium tip did not separate and remained attached to the catheter. The procedure was subsequently completed using alternative methods. Due to a patient infection, this device could not be retrieved. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706842 ↗InjuryAug 28, 2026Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent a recanalization procedure using a Crosser IQ catheter. During the procedure, the marker band allegedly detached from the device and remained within the patients body. There was no reported patient injury.
Patient problems: Foreign Body In Patient
MAUDE report 50501585 ↗MalfunctionAug 26, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454414 ↗MalfunctionAug 25, 2026Material Separation
On Aug 07, 2026, a patient underwent a recanalization procedure using a Crosser IQ catheter. During the procedure, it was reported that the catheter tip became detached; however, the tip remained attached to the core wire. It was further reported that the core wire had stretched. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427816 ↗MalfunctionAug 18, 2026Material Separation; Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50293697 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent a recanalization procedure using a Crosser IQ catheter via a contralateral femoral approach for the treatment of a calcified superficial femoral artery (SFA) lesion. During the procedure, it was reported that the catheter tip detached after approximately 2 minutes of use. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292951 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292950 ↗MalfunctionAug 13, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233643 ↗MalfunctionAug 10, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190755 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent a recanalization procedure using the Crosser iQ catheter. During the procedure, the tip allegedly detached. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190108 ↗MalfunctionJul 27, 2026Material Separation
On (b)(6) 2026, a patient underwent recanalization procedure using the Crosser IQ catheter. During the procedure, it was reported that the tip allegedly was detached. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020787 ↗MalfunctionJun 23, 2026Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP ALLEGEDLY DETACHED AFTER APPROXIMATELY THREE MINUTES, BUT IT WAS STILL ATTACHED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25589726 ↗MalfunctionJun 20, 2026Material Separation; Failure to Advance
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, ON FIRST ATTEMPT THE CROSSER WAS UNABLE TO CROSS THE LESION AND ON SECOND ATTEMPT THE TIP SEPARATED FROM THE COREWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25569097 ↗MalfunctionJun 20, 2026Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING A CROSSER IQ CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER TIP ALLEGEDLY BROKE FROM THE SHAFT AND WAS OBSERVED TO BE DETACHED BUT NOT COMPLETELY SEPARATED. THE TIP REMAINED ATTACHED TO THE CORE WIRE, AND NO FRAGMENT WAS LEFT BEHIND IN THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25568958 ↗MalfunctionJun 9, 2026Material Separation; Improper or Incorrect Procedure or Method
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER TIP WAS ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441809 ↗MalfunctionJun 8, 2026Break; Material Separation; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, AFTER PASSING THROUGH THE WIRE VASSALLO SUPPORT IN A RIGHT CFA CALCIFIED LESION VIA A LEFT CONTRALATERAL APPROACH, THE PATIENT ATTEMPTED TO INSERT THE WIRE INTO THE CROSSER IQ, BUT THE GUIDEWIRE WAS RELUCTANT TO GO IN AT ALL, AND THERE WAS NO WAY TO GET THE WIRE CAUGHT IN THE GUIDEWIRE PORT AND NO WAY TO GET THE WIRE OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423276 ↗MalfunctionJun 1, 2026Material Separation; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2026, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. PRIOR TO THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE OVER THE GUIDE WIRE LUMEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25345885 ↗MalfunctionMay 28, 2026Break; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY DID NOT PASS THROUGH THE EXIT PORT OF THE CATHETER AND STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25312345 ↗MalfunctionMay 26, 2026Material Separation
A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER WAS DISCONTINUED DUE TO POSSIBLE DAMAGE TO THE TIP AND THE END POINT. IT WAS LATER CONFIRMED THAT THE TIP, END POINT AND SHAFT WERE DETACHED FROM THE ADHESIVE, AND NO COMPLETE SEPARATION WAS OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273714 ↗MalfunctionMay 22, 2026Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER TIP WAS ALLEGEDLY DETACHED BUT IT WAS STILL CONNECTED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25251439 ↗MalfunctionMay 20, 2026Material Split, Cut or Torn
ON (B)(6) 2026, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY SPLINTERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25226390 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.