CROSSERRecalls & reported problems across all models

We found 6 models of CROSSER by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2016 and Dec 1, 2025 — classified as 9 injuries, 151 malfunctions.

The most frequently reported specific device problem is “Material Separation” (65 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CROSSER problems

CROSSER models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CROSSER® CRUO14SA

  Catheter for crossing total occlusions
  60 reports
• CROSSER® CRUS6A

  Catheter for crossing total occlusions
  47 reports
• CROSSER® CRU14SA

  Catheter for crossing total occlusions
  20 reports
• CROSSER® CRUOS106

  Catheter for crossing total occlusions
  18 reports
• CROSSER® CRUS6106

  Catheter for crossing total occlusions
  12 reports
• CROSSER® CRUS106

  Catheter for crossing total occlusions
  3 reports

Recent CROSSER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678676 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566003 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554107 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553249 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PREPARATION OF THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS NO DAMAGE NOTED ON THE BOX. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551735 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551257 ↗
• MalfunctionAug 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE WIRE PORT, THE VALVE WAS ALLEGEDLY COMPLETELY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881929 ↗
• MalfunctionAug 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE WIRE PORT, THE VALVE WAS ALLEGEDLY COMPLETELY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881926 ↗
• MalfunctionMar 17, 2025Material Separation; Material Twisted/Bent; Activation Problem; Material Separation; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY HAD A CHIRP VIBRATION. THE PROCEDURE WAS COMPLETED TREAT WITH ANGIOPLASTY AND STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615734 ↗
• MalfunctionJan 24, 2025Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY STICK TO THE WIRE. IT WAS FURTHER REPORTED THAT THE WIRE ACCESS WAS LOST WHILE TRYING TO RETRIEVE THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231529 ↗
• MalfunctionDec 13, 2023Break; Difficult to Remove; Device-Device Incompatibility; Activation Problem; Break; Difficult to Remove; Device-Device Incompatibility; Activation Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE ALLEGEDLY STOPPED WORKING AND THE CATHETER ALLEGEDLY GOT STUCK IN THE SUPPORT CATHETER. REPORTEDLY BOTH THE CATHETERS WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316956 ↗
• MalfunctionAug 30, 2023Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY WOULD NOT CONNECT TO THE TRANSDUCER CABLE. IT WAS FURTHER REPORTED THAT WHEN THEY TRIED TO UNSCREW THE CATHETER FROM THE CABLE TO CATHETER HOUSING CAME APART EXPOSING THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648142 ↗
• MalfunctionJul 11, 2023Retraction Problem; Stretched; Detachment of Device or Device Component; Retraction Problem; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE, THE CATHETER TIP ALLEGEDLY BROKE WHEN THE DEVICE WAS BEING PULLED BACK OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS UNABLE TO BE RETRIEVED AS THE VESSEL WAS COMPLETELY OCCLUDED WHERE THE TIP WAS BROKEN OFF. REPORTEDLY, THE CATHETER TIP WAS LEFT IN THE PATIENT. FURTHERMORE, NO ADDITIONAL TREATMENT WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300213 ↗
• MalfunctionMay 30, 2023Break; Retraction Problem; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent; Break; Retraction Problem; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE LEFT SUPERFICIAL ARTERY VIA RIGHT GROIN ACCESS, THE CATHETER ALLEGEDLY BECAME STUCK IN THE LESION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY COMPLETELY BROKEN AND STUCK INSIDE THE SUPPORT CATHETER. FURTHERMORE, THE CATHETER ALLEGEDLY HAD DIFFICULTY IN REMOVING FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE FROM THE PATIENT WITHOUT RIPPING THE VESSEL APART. THE CROSSER IS STILL STUCK INSIDE THE SUPPORT CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018301 ↗
• MalfunctionApr 4, 2023Break; Crack; Leak/Splash; Break; Crack; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN WHEN IT WAS OPENED. IT WAS FURTHER REPORTED WHEN THE CATHETER WAS FLUSHED, THERE WAS SOME FLUID COMING OUT OF THE SIDE OF THE CATHETER JUST ABOUT AN INCH FROM THE PORT. REPORTEDLY UPON CLOSER OBSERVATION, THERE WAS A SMALL CRACK IN THE SIDE OF THE CATHETER THAT WAS LEAKING FLUID. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672349 ↗

Other Bard Peripheral Vascular, Inc. products

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