Reliant™ REL46 (UDI 00643169707641)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169707641), received between Aug 10, 2017 and Mar 19, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2018Break; Inability to Irrigate; Break; Inability to Irrigate

  A RELIANT BALLOON WAS USED IN THE ENDOVASCULAR TREATMENT OF THE PATIENT FOR A 5MM ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A SYRINGE WAS ATTACHED TO THE PLASTIC DISTAL PART OF THE FLUSH PORT IN ORDER TO FLUSH SALINE THROUGH THE DEVICE. WHEN THE SURGEON WENT TO ADVANCE THE SALINE IT SPRAYED OUT THE SIDE OF THE PLASTIC AND THE PHYSICIAN SAID IT LOOKED LIKE IT WAS CRACKED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DUE TO THE A CRACK IN THE FLUSH PORT OF THE RELIANT BALLOON. IT WAS NOTED THAT THE EVENT WAS RESOLVED WITH THE USE OF ANOTHER RELIANT BALLOON ON THE SAME DAY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. MEDICAL HISTORY; (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349116 ↗
• MalfunctionFeb 20, 2018Material Rupture; Material Rupture

  A RELIANT BALLOON WAS USED IN THE ENDOVASCULAR TREATMENT OF THE PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHEN BALLOONING THE DISTAL AORTA, THE PROXIMAL STENT GRAFT AND THE STENT GRAFT OVERLAP SECTIONS WERE BALLOONED WITH NO ISSUE. IT IS NOTED THAT A KISSING TECHNIQUE WAS PERFORMED IN THE DISTAL AORTA AND THAT THE BALLOONS WHERE MOVED TO THE ILIAC LIMBS (16X10X124) AND INFLATED AT THE SAME TIME. BOTH BALLOONS BURST AT THE SAME TIME IN THE PROXIMAL COMMON ILIAC ARTERIES. THE EVENT WAS RESOLVED WITH THE REPLACEMENT OF THE BALLOONS AND THE PROCEDURE WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282145 ↗
• MalfunctionAug 18, 2017Material Rupture; Material Rupture

  A RELIANT BALLOON WAS USED IN A PATIENT TO MODEL AN ENDURANT [16X13X199] STENT GRAFT LIMB. A 20CC SYRINGE FILLED WITH A 70% SALINE AND 30% CONTRAST WAS USED TO INFLATE THE BALLOON WITH MODERATELY APPLIED PRESSURE. BALLOONING BEGAN POST STENT GRAFT PLACEMENT AT THE PROXIMAL END OF THE STENT GRAFT. ON APPROXIMATELY THE THIRD OVERLAPPING INFLATION, MOVING DISTAL WITHIN THE LIMB, THE BALLOON RUPTURED WITH APPROXIMATELY 5CC OF INJECTION. THE STENT GRAFT REMAINED IN PLACE. A NEW BALLOON WAS USED AND THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803129 ↗
• MalfunctionAug 10, 2017Difficult to Insert; Difficult to Insert

  A RELIANT BALLOON WAS USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM. IT WAS REPORTED THAT THE RELIANT BALLOON WOULD NOT FIT THOUGH A 12 FR SHEATH. THE PHYSICIAN FELT SOMETHING ¿POP¿ IN THE BALLOON AND WAS UNCOMFORTABLE CONTINUING TO USE IT. ANOTHER RELIANT BALLOON WAS OPENED AND FIT INTO THE SHEATH, THIS RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6783877 ↗