PX SLIM Delivery Microcatheter PXSLIM130-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010465), received between May 3, 2016 and May 3, 2016 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A PX SLIM; HOWEVER, WHILE REPOSITIONING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. UPON REMOVING THE PX SLIM, THE DETACHED RUBY COIL REMAINED IN THE PATIENT AND WAS REMOVED USING A SNARE DEVICE. WHILE ADVANCING A NEW RUBY COIL THROUGH A NEW PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PX SLIM AND DETACHED RUBY COIL WERE BOTH REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5626208 ↗