DESTINATION RSP02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701007793), received between May 19, 2016 and Aug 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE DOCTOR COULD NOT GET DESTINATION DEVICE UP AND OVER. AS HE PULLED IT OUT, THE DISTAL END WAS PEELING AND WOULD NOT FLUSH THE SHEATH. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21JULY2021: THE PROCEDURE PERFORMED FOR THE PATIENT AT THE TIME THIS EVENT OCCURRED WAS PAD. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. NO OTHER DEVICES WERE USED WITH THE ABOVE PRODUCT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12262432 ↗
• MalfunctionMar 5, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH HUB WAS BROKEN BEFORE IT WAS REMOVED FROM THE PACKAGE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 13FEB2020. IT WAS NOT USED IN THE PROCEDURE ROOM WITH A PATIENT. IT WAS BEING PUT ONTO THE PREP TABLE. THE HUB WAS THE COMPONENT THAT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793658 ↗
• MalfunctionMay 19, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A 6FR SHEATH WAS LEAKING BADLY AT THE VALVE DURING A TAVR CASE; BLOOD LOSS WAS LESS THAN 250ML; IT WAS REPORTED BUT NOT CONFIRMED THAT THE LEAKING COULD HAVE BEEN BECAUSE A 0.035 AMPLATZ STIFF WIRE WAS LEFT IN THE VALVE WITHOUT THE CATHETER AND NOT CENTERED; (4) THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 5667606 ↗