NYLEX 526510Recalls & reported problems
Cordis Corporation · CATH NYLEX 5F PIG 65CM 8SH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032010665), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 injury.
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 Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE DISTAL PART OF 5F 0.35 65CM NYLEX PIGTAIL (PIG) WITH 8 SIDE HOLES (SH) DIAGNOSTIC CATHETER WAS TORN WHEN IT WAS INSIDE THE PATIENT. PART OF THE PIGTAIL REMAINED IN THE PATIENT. THEREFORE, THE DOCTOR REMOVED THE PIECE USING A GUIDING CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS ENDOVASCULAR PROSTHESIS CASE. THE DOCTOR USED THE PRODUCT ON RIGHT CONDITION. THE DOCTOR FIRST FELT THAT THE RINGS WERE RETRACTED AND THEN HE WOULD TEAR. THE DEVICE WILL BE NOT RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10010587 ↗
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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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