NYLEX 526410Recalls & reported problems
Cordis Corporation · CATH NYLEX 4F 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 10705032010535), received between Jun 15, 2021 and Jun 15, 2021 — 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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DURING AN ANGIOGRAM PROCEDURE, THE PIGTAIL OF A 4F 65CM 8-SIDE HOLES (8SH) PIGTAIL NYLEX DIAGNOSTIC CATHETER FRACTURED, LEAVING THE PIGTAIL PART OF THE CATHETER INSIDE THE PATIENT. THE DOCTOR WAS ABLE TO SUCCESSFULLY REMOVE A PIECE OF THE CATHETER USING A SNARE. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE HAD KINKED IN THE AREA OF SEPARATION. THE PATIENT IS DOING "FINE". THERE WAS NO OTHER REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED FOR A CTO. THE DEVICE WAS NOT RESTERILIZED. THE USER WAS TRAINED WITH THE DEVICE. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE SEPARATION WAS APPROXIMATELY 50CM FROM THE DISTAL END. THE SEPARATED PIECE DID NOT EMBOLIZE AND WAS SNARED FROM THE ILIAC ARTERY/COMMON FEMORAL ARTERY (CFA). OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 11999791 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page