CrossCath G51573Recalls & reported problems
Cook Incorporated · CrossCath Support Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002515734), received between Oct 30, 2017 and Oct 31, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
- Device Dislodged or Dislocated1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2017Break
AS REPORTED TO CUSTOMER RELATIONS A WIRE ACCORDIONED INSIDE CATHETER, A DIFFERENT WIRE WAS USED AND SAME THING HAPPENED. THE CATHETER AND WIRE WERE PULLED OUT AND THE CATHETER HAD BUNCHED UP ON THE WIRE. ALSO, THE HUB BROKE. A NEW CATHETER AND WIRE WERE OBTAINED TO FINISH THE PROCEDURE AS NORMAL. THERE WERE NO ISSUES WITH THE NEW CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6991052 ↗MalfunctionOct 30, 2017Break; Device Dislodged or Dislocated
AS REPORTED TO CUSTOMER RELATIONS, THE WIRE ACCORDIONED INSIDE CATHETER. A DIFFERENT WIRE WAS USED BUT THE SAME THING HAPPENED. THE CATHETER AND WIRE WERE PULLED OUT AND CATHETER HAD BUNCHED UP ON THE WIRE. ALSO, THE HUB BROKE. A NEW CATHETER AND WIRE WERE USED TO FINISH THE PROCEDURE AS NORMAL. THERE WERE NO ISSUES WITH THE NEW CATHETER. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE SECOND WIRE THAT WAS OPENED WAS FROM THE SAME LOT NUMBER. ACCORDING TO THE DISTRICT MANAGER, THERE WERE NO ADDITIONAL PROCEDURES, NO ADVERSE EFFECTS REPORTED. THE HUB OF THE CATHETER BROKE OFF, BUT IT DID NOT REMAIN IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6987968 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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