NYLEX 526540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032010771), received between Mar 14, 2019 and Jan 4, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2021Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE DOCTOR WAS COMPLETING A RUNOFF PROCEDURE AND HE WAS TOWARDS THE END OF THE PROCEDURE AND REMOVED THE UNKNOWN WIRE TO TAKE PICTURES. HOWEVER, THE USER COULDN¿T GET A 5F 65CM 8 SIDE HOLES (SH) UNIVERSAL FLUSH (UF) NYLEX DIAGNOSTIC CATHETER TO MOVE AND THE UNKNOWN WIRE WOULD NOT ADVANCE. THE USER ¿ADVANCED THE WIRE TO STRENGTHEN OUT THE KINK IN THE CATHETER IN THE ¿HORN¿ OF THE CATHETER¿. WHEN THE USER FINALLY WAS ABLE TO REMOVE THE CATHETER, THERE WAS A HOLE THAT WAS NOT THERE BEFORE. THE PROCEDURE WAS COMPLETED WITH A 4F NON-CORDIS CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108501 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF TWO NYLEX CATHETERS 5F UF 65CM 8SH BLEW OFF WHEN THE USER WAS GOING TO USE IT. THE EVENT HAPPENED IN THE PATIENT. THE END OF THE DEVICE THAT BLEW OFF, BLEW OFF OUTSIDE OF THE PATIENT. THE REMAINING PIECE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NYLEX CATHETER FROM A DIFFERENT LOT. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICES WERE STORED ON A HANGING RACK ENCLOSED BY A VINYL COVER. THE DEVICES WERE NOT STORED FOR MORE THAN FOUR MONTHS. THE DEVICES WERE STORED IN TEMPERATURE/HUMIDITY-CONTROLLED ROOMS. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICES INTO THE PATIENT. THERE WERE NO DAMAGES NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGES. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THE EVENT HAPPENED IN THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422413 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF TWO NYLEX CATHETERS 5F UF 65CM 8SH BLEW OFF WHEN THE USER WAS GOING TO USE IT. THE EVENT HAPPENED IN THE PATIENT. THE END OF THE DEVICE THAT BLEW OFF, BLEW OFF OUTSIDE OF THE PATIENT. THE REMAINING PIECE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NYLEX CATHETER FROM A DIFFERENT LOT. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICES WERE STORED ON A HANGING RACK ENCLOSED BY A VINYL COVER. THE DEVICES WERE NOT STORED FOR MORE THAN FOUR MONTHS. THE DEVICES WERE STORED IN TEMPERATURE/HUMIDITY-CONTROLLED ROOMS. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICES INTO THE PATIENT. THERE WERE NO DAMAGES NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGES. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THE EVENT HAPPENED IN THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422394 ↗