CROSSER® CRUO14SARecalls & reported problems
Bard Peripheral Vascular, Inc. · CROSSER® CTO Recanalization Catheter 14S, Over the Wire, 146cm · Class 2
All models of CROSSER (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
The Bard CROSSER® CTO catheter is used to open up fully blocked arteries. Most reports describe parts of the catheter coming apart — the wire port or valve breaking off, the shaft separating, twisting or snapping — often so the procedure has to be finished with another device. There are 60 reports:59 malfunctions and 1 injury, no deaths. No recalls name this device.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10801741125598), received between Jun 23, 2016 and Dec 1, 2025 — classified as 1 injury, 59 malfunctions.
The most frequently reported specific device problem is “Material Separation” (40 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation40
- Device-Device Incompatibility22
- Detachment of Device or Device Component15
- Material Twisted/Bent15
- Break7
- Material Puncture/Hole4
- Retraction Problem4
- Activation Problem3
Patient problems
- No Patient Involvement21
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient19
Recent adverse event reports
The 25 most recent of 60 reports, 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 ↗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 ↗MalfunctionApr 7, 2022Retraction Problem; Material Separation; Device-Device Incompatibility; Material Deformation; Retraction Problem; Material Separation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA SUPERFICIAL FEMORAL ARTERY , THE CATHETER WAS ALLEGEDLY HAD RETRACTION ISSUE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY HAD INCOMPATIBILITY ISSUE. REPORTEDLY THE CATHETER AND WIRE REMOVED AS A SINGLE UNIT AND LOST WIRE ACCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14038053 ↗MalfunctionFeb 11, 2022Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY BROKE AND THERE WAS A SEPARATION AT THE TIP. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE SUPPORT CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13511508 ↗MalfunctionJan 24, 2022Material Separation; Material Separation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE THROUGH LEFT SUPERFICIAL FEMORAL ARTERY (SFA) , THE DEVICE TIP ALLEGEDLY SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13331393 ↗MalfunctionJan 24, 2022Material Separation; Material Separation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE THROUGH LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE DEVICE TIP ALLEGEDLY SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13330706 ↗MalfunctionNov 26, 2021Retraction Problem; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER COULD NOT BE RETRIEVED FROM SUPPORTING CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12878032 ↗MalfunctionNov 10, 2021Material Puncture/Hole; Material Separation; Failure to Advance; Material Twisted/Bent; Material Split, Cut or Torn; Material Puncture/Hole; Material Separation; Failure to Advance; Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12785246 ↗MalfunctionOct 20, 2021Melted; Material Separation; Melted; Material Separation
IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662721 ↗MalfunctionJun 18, 2021Material Separation; Material Separation
IT WAS REPORTED THAT DURING PREPARATION OF THE RECANALIZATION PROCEDURE, THE DISTAL TIP OF THE DEVICE ALLEGEDLY SEPARATED FROM THE CATHETER WHILE BEING INSERTED INTO THE SHEATH. THERE WERE NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12022899 ↗MalfunctionJun 18, 2021Material Separation; Material Separation
IT WAS REPORTED THAT DURING PREPARATION OF THE RECANALIZATION PROCEDURE, THE DISTAL TIP OF THE DEVICE ALLEGEDLY SEPARATED FROM THE CATHETER WHILE BEING INSERTED INTO THE SHEATH. THERE WERE NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12022848 ↗MalfunctionFeb 2, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DISTAL END OF THE WIRE ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE BROKEN WIRE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11264522 ↗MalfunctionOct 28, 2020Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUO14SA RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750304 ↗MalfunctionJul 16, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUO14SA RECANALIZATION CATHETERS ALLEGEDLY EXPERIENCED DETACHMENT AND FAILURE TO ADVANCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284919 ↗MalfunctionJul 14, 2020Retraction Problem; Material Separation; Retraction Problem; Material Separation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CRUO14SA RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND MATERIAL SEPARATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A 60 YEAR OLD MALE PATIENT'S WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10274261 ↗MalfunctionJul 13, 2020Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CRUO14SA RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND DEVICE-DEVICE INCOMPATIBILITY. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10268724 ↗MalfunctionJul 13, 2020Material Separation; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Material Separation; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUO14SA RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED DEVICE-DEVICE INCOMPATIBILITY, MATERIAL SEPARATION AND MATERIAL TWIST. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE 72 YEAR OLD FEMALE PATIENT WAS 120 LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10268722 ↗
Other Catheter for crossing total occlusions devices
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- Approach G50787Cook Incorporated · Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50788Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50789Cook Incorporated · Catheter for crossing total occlusions2 recalls0 reports
- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page