Fusion Oasis G31527Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002315273), received between Jun 29, 2017 and Jan 10, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2019Material Integrity Problem; Material Integrity Problem

  AS REPORTED TO CUSTOMER RELATIONS: "UNKNOWN FAILURE. DEVICES WERE ALL STORED TOGETHER BUT UNKNOWN IF THEY'D BEEN USED TOGETHER OR HOW LONG ANY OF THEM HAD BEEN THERE FOR. JUST FOUND. TRIED TO GET ADDITIONAL DETAILS FROM STAFF AND THEY DIDN'T KNOW ANYTHING ABOUT THE FAILURES OR USAGE OF THE DEVICES, ONLY THAT THEY WERE "DEFECTIVE" AND AVAILABLE FOR RETURN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235560 ↗
• MalfunctionMay 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ¿THE INNER CATHETER SNAPPED DURING DEPLOYMENT¿ AS WE WERE DEPLOYING THE STENT THE INTRODUCER SNAPPED AND BROKE OFF. IT DIDN¿T FEEL ANY STIFFER THAN USUAL. THE INNER PART OF THE PUSHER WHICH YOU UNLOCK AND PULL BACK AS YOU PUSH THE STENT IS WHAT BROKE OFF. WE WERE STILL ABLE TO DEPLOY THE STENT SAFELY. WE WERE NOT SURE IF THE STENT PUSHER WAS FAULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557193 ↗
• MalfunctionMay 22, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS, "TWO HOBBS FREEMAN 10X10 DOUBLE PIG TAIL STENTS WERE REMOVED FROM THE AMPULA. PHYSICIAN CANNULATED WITH A .035X450 JAG WIRE GUIDE THRU THE FUSION QUATRO EXTRACTION BALLOON. THREE SWEEPS OF THE BILE DUCT WERE PERFORMED AND PHYSICIAN LEFT THE LONG WIRE GUIDE IN POSITION AND HAD THE TECH PREPARE THE SOLUS 10X10 STENT FOR TRIAL. INTRODUCER GUIDING CATHETER WAS LIGHTLY LUBRICATED USING SURGI LUBE. STENT WAS LOADED ONTO GUIDING CATHETER AND THEN ONTO WIRE GUIDE. DIFFICULTY WAS EXPERIENCED ONCE IN THE DUCT GETTING THE STENT INTO POSITION. PHYSICIAN NOTED PUSHING CATHETER WAS BUCKLING AT THE BIOPSY PORT. GUIDING CATHETER WAS SLOWLY REMOVED ONCE THE PHYSICIAN HAD THE STENT INTO POSITION. GUIDING CATHETER STRETCHED AND BROKE MULTIPLE TIMES DURING REMOVAL. FINALLY, STENT WAS PLACED SUCCESSFULLY. PHYSICIAN WANTED TO PLACE A SECOND 10X10 DOUBLE PIG TAIL STENT, SO A HOBBS FREEMAN 10X10 DOUBLE PIGTAIL WAS LOADED ONTO A FUSION OASIS 10FR INTRODUCER. GUIDING CATHETER WAS LIGHTLY LUBED PRIOR TO STENT PLACEMENT. ONCE STENT INTO POSITION AND GUIDING CATHETER UP IN THE DUCT, PHYSICIAN ASKED THE GUIDING CATHETER TO BE REMOVED AND STRETCHING AND BREAKING OCCURRED AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533453 ↗
• MalfunctionNov 14, 2017Stretched; Stretched

  THIS FOLLOW UP MDR IS BEING SUBMITTED FOR CANCELLATION AND TO INCLUDE THE INVESTIGATION FINDINGS. UPON PLACING THE STENT, THE TECH WAS PULLING OUT INSIDE GUIDING CATHETER AND EXPERIENCED DIFFICULTY WITHDRAWING CATHETER. GAVE A LITTLE MORE EFFORT AND CATHETER STRETCHED ((B)(4)). A SECOND DEVICE WAS USED AND THE TECH WAS PULLING OUT INSIDE GUIDING CATHETER AND EXPERIENCED DIFFICULTY WITHDRAWING CATHETER. GAVE A LITTLE MORE EFFORT AND THE WHOLE HANDLE STRETCHED AND PULLED RIGHT OFF THE GUIDING CATHETER ((B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7027915 ↗
• MalfunctionNov 14, 2017Stretched; Stretched

  THIS FOLLOW UP MDR IS BEING SUBMITTED FOR CANCELLATION AND TO INCLUDE THE INVESTIGATION FINDINGS. UPON PLACING THE STENT, THE TECH WAS PULLING OUT INSIDE GUIDING CATHETER AND EXPERIENCED DIFFICULTY WITHDRAWING CATHETER. GAVE A LITTLE MORE EFFORT AND CATHETER STRETCHED ((B)(4)). A SECOND DEVICE WAS USED AND THE TECH WAS PULLING OUT INSIDE GUIDING CATHETER AND EXPERIENCED DIFFICULTY WITHDRAWING CATHETER. GAVE A LITTLE MORE EFFORT AND THE WHOLE HANDLE STRETCHED AND PULLED RIGHT OFF THE GUIDING CATHETER ((B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7027733 ↗
• MalfunctionJul 5, 2017Material Separation; Material Separation

  THIS REPORT IS BEING SUBMITTED DUE TO THE DEVICE EVALUATION. AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ERCP PROCEDURE, THE 10FR-10CM FREEMAN STENT DOUBLE PIGTAIL WAS USED WITH A COOK INTRODUCER AND UPON WITHDRAWING OF THE INNER GUIDING CATHETER THE TECH EXPERIENCED EXTREME DIFFICULTY PULLING BACK ON THE CATHETER. WITH A STRONG PULL THE CATHETER SNAPPED SEPARATING THE HANDLE FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE STENT OVER THE REMAINING PORTION OF CATHETER AND WAS ABLE TO DEPLOY THE STENT. IT DETACHED IN THE HAND OF THE TECH WHILE THE PHYSICIAN HAD CONTROL OF THE PUSHING CATHETER AND THE GUIDING CATHETER. TWO DEVICES WERE USED IN THIS PROCEDURE AND WITH IDENTICAL EVENTS PER DEVICE (REF#S 3001845648-2017-00258 AND 3001845648-2017-00259). THERE WAS NO HARM TO THE PATIENT AND NOTHING REMAINED IN THE PATIENT BUT THE INTENDED STENTS THAT WERE DEPLOYED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685820 ↗
• MalfunctionJul 5, 2017Material Separation; Material Separation

  THIS REPORT IS BEING SUBMITTED DUE TO DEVICE EVALUATION. AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ERCP PROCEDURE, THE 10FR-10CM FREEMAN STENT DOUBLE PIGTAIL WAS USED WITH A COOK INTRODUCER AND UPON WITHDRAWING OF THE INNER GUIDING CATHETER THE TECH EXPERIENCED EXTREME DIFFICULTY PULLING BACK ON THE CATHETER. WITH A STRONG PULL THE CATHETER SNAPPED SEPARATING THE HANDLE FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE STENT OVER THE REMAINING PORTION OF CATHETER AND WAS ABLE TO DEPLOY THE STENT. IT DETACHED IN THE HAND OF THE TECH WHILE THE PHYSICIAN HAD CONTROL OF THE PUSHING CATHETER AND THE GUIDING CATHETER. TWO DEVICES WERE USED IN THIS PROCEDURE AND WITH IDENTICAL EVENTS PER DEVICE (REF#S 3001845648-2017-00258 AND 3001845648-2017-00259). THERE WAS NO HARM TO THE PATIENT AND NOTHING REMAINED IN THE PATIENT BUT THE INTENDED STENTS THAT WERE DEPLOYED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685744 ↗
• MalfunctionJun 29, 2017Material Perforation; Material Perforation

  THIS INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'STYLET WIRE/SHEATH PERFORATION'. AS PER CC FORM: THE DOCTOR NOTICED A METAL WIRE COMING OUT OF THE TIP OF THE OASIS. TOOK A NEW OASIS TO FINISH THE PROCEDURE. METAL WIRE CAME OUT OF THE TIP. BEHIND THE RADIO THE WIRE COMES OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676246 ↗