DESTINATION RSR13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701006970), received between Dec 29, 2016 and Sep 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WOULD NOT CROSS THE VESSEL. THE DOCTOR CHANGED TO A COOK SHUTTLE AND FINISHED THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 26AUG2019. THERE WAS NO SIGN OF DAMAGE TO THE DESTINATION. THE PROCEDURE WAS AN INSERTION. THE DESTINATION WAS UNABLE TO PENETRATE THE SKIN AND VASCULAR WALL. THE DEVICE DID NOT ENTER PATIENT'S BODY. THE PATIENT'S CONDITION WAS STABLE. AFTER USING THE OTHER DEVICE, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962279 ↗
• MalfunctionDec 29, 2016Material Separation; Material Separation

  THE USER FACILITY REPORTED DAMAGE ON THE DESTINATION DEVICE. FOLLOW UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: WHEN THE MD OPENED THE PACKAGE IT LOOKED LIKE THE DILATOR TO SHEATH TRANSITION WAS JAGGED OR ROUGH; THE DEVICE IN QUESTION WAS NOT USED ON THE PATIENT; ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6212569 ↗