NYLEX 526530Recalls & reported problems
Cordis Corporation · CATH NYLEX 5F PIG TR 65CM 8SH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032010740), received between May 8, 2019 and May 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING THE INJECTION OF THE CONTRAST PRODUCT WITH AN AUTOMATIC INJECTOR (40CC TO 20CC/SECOND, MAXIMUM PRESSURE 723 PSI) TO PERFORM A PULMONARY ANGIOGRAPHY, THE 5F PIGTAIL CATHETER (CATH NYLEX 5F PIG TR 65CM 8SH) BROKE AT 4CM FROM THE BASE WHICH CAUSED A DELAY IN MANAGING THE PATIENT. THE DEVICE WAS RECEIVED IN TWO PIECES. (B)(6) CONFIRMED THAT THE HUB HAD SEPARATED FROM THE BODY SHAFT OF THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8590821 ↗
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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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