Dreamwire M00556160Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729779605), received between Dec 28, 2017 and Aug 14, 2026 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246168 ↗
• MalfunctionMay 30, 2023Material Deformation; Material Deformation

  NOTE: THIS REPORT PERTAINS TO TWO WALLFLEX FULLY COVERED BILIARY STENTS AND A DREAMWIRE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO WALLFLEX FULLY COVERED BILIARY STENTS AND A DREAMWIRE WERE USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY, STONE REMOVAL, AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST WALLFLEX BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-02837) WAS DEPLOYED; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE DELIVERY SYSTEM. SUBSEQUENTLY, THE STENT AND THE GUIDEWIRE WERE REMOVED ALONG WITH THE DELIVERY SYSTEM. A SECOND WALLFLEX BILIARY STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED; HOWEVER, THE SAME PROBLEM OCCURRED. REPORTEDLY, THE GUIDEWIRE WAS KINKED. THE PROCEDURE WAS CANCELED AND RESCHEDULED ON (B)(6) 2023 DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026154 ↗
• MalfunctionAug 15, 2022Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE DREAMWIRES WERE USED DURING AN ENDOSCOPIC ULTRASOUND HEPATICOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED THROUGH A 19GA EXPECT EUS NEEDLE TO GAIN ACCESS INTO THE DESIRED DUCT. WHILE MANIPULATING THE GUIDEWIRE, THE HYDROPHILIC COATING WAS SCATHED OFF BY THE END OF THE EUS NEEDLE. THREE DREAMWIRES WERE USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO NOT BEING ABLE TO GAIN CORRECT ACCESS OF INTRAHEPATIC DUCTS AND WAS REFERRED TO INTERVENTIONAL RADIOLOGY. PER THE DREAMWIRE IFU (50693808 REV B) THERE IS "CAUTION: DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE THE SURFACE OF THE GUIDEWIRE."THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229440 ↗
• MalfunctionAug 15, 2022Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE DREAMWIRES WERE USED DURING AN ENDOSCOPIC ULTRASOUND HEPATICOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED THROUGH A 19GA EXPECT EUS NEEDLE TO GAIN ACCESS INTO THE DESIRED DUCT. WHILE MANIPULATING THE GUIDEWIRE, THE HYDROPHILIC COATING WAS SCATHED OFF BY THE END OF THE EUS NEEDLE. THREE DREAMWIRES WERE USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO NOT BEING ABLE TO GAIN CORRECT ACCESS OF INTRAHEPATIC DUCTS AND WAS REFERRED TO INTERVENTIONAL RADIOLOGY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PER THE DREAMWIRE IFU (50693808 REV B) THERE IS "CAUTION: DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE THE SURFACE OF THE GUIDEWIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229436 ↗
• MalfunctionAug 15, 2022Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE DREAMWIRES WERE USED DURING AN ENDOSCOPIC ULTRASOUND HEPATICOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED THROUGH A 19GA EXPECT EUS NEEDLE TO GAIN ACCESS INTO THE DESIRED DUCT. WHILE MANIPULATING THE GUIDEWIRE, THE HYDROPHILIC COATING WAS SCATHED OFF BY THE END OF THE EUS NEEDLE. THREE DREAMWIRES WERE USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO NOT BEING ABLE TO GAIN CORRECT ACCESS OF INTRAHEPATIC DUCTS AND WAS REFERRED TO INTERVENTIONAL RADIOLOGY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PER THE DREAMWIRE IFU (50693808 REV B) THERE IS "CAUTION: DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE THE SURFACE OF THE GUIDEWIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229353 ↗
• MalfunctionDec 31, 2020Difficult to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-06471 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 6CM MALIGNANT COLONIC OBSTRUCTION IN THE SIGMOID COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, POST PATIENT SEDATION, THE PHYSICIAN HAD DIFFICULTY PASSING THE DELIVERY SYSTEM OVER THE GUIDEWIRE AND HAD DIFFICULTY ADVANCING THE DELIVERY SYSTEM TOWARDS THE ANATOMY. REPORTEDLY, THE DREAMWIRE GUIDEWIRE (THE SUBJECT OF THIS REPORT) GOT KINKED. THE PHYSICIAN WANTED TO EXCHANGE THE GUIDEWIRE; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FROM THE SCOPE, THE WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2020-06471) DEPLOYED PREMATURELY INSIDE THE SCOPE. THE STENT WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11100526 ↗
• MalfunctionMay 4, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE ON (B)(6) 2020, A HOLE WAS FOUND IN THE DEVICE POUCH. REPORTEDLY, IT IS UNKNOWN IF STERILE BARRIER WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021339 ↗
• MalfunctionJan 24, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE¿ GUIDEWIRE WAS USED DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT PASS SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED ON JANUARY 17, 2018 THAT THE CORE WIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216711 ↗
• DeathDec 28, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS USED IN THE BILE DUCT AND DUODENUM DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED DUE TO STENOSIS OF THE BILE DUCT AND DUODENUM WHICH DOES NOT ALLOW DRAINAGE OF BILE DUCTS BY RETROGRADE APPROACH. DURING THE PROCEDURE, TO ADDRESS THE DRAINAGE PROBLEM, TRANSHEPATIC ECHO-ENDOSCOPIC CONTROL APPROACH WAS PERFORMED. THE DREAMWIRE GUIDEWIRE WAS INSERTED FIRST, AND THEN A NON-BSC ASPIRATION NEEDLE WITH 19GEZ SHOT WAS THEN PLACED. IT WAS NOTICED THAT THE GUIDEWIRE PEELED WITH THE NEEDLE, LEADING TO THE BLOCKAGE OF THE GUIDEWIRE. THE OUTER SHEATH OF THE GUIDEWIRE BROKE AND STUCK INSIDE THE CYSTOSTOME. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, WHICH WAS REPORTEDLY RISK FOR BILIARY FISTULA. THE PATIENT WAS TREATED WITH ANTIBIOTIC DUE TO DRAINAGE FAILURE. 5 DAYS LATER, THE PATIENT HAD BILE IN THE PERITONEUM THRU EXPLORATORY LAPAROTOMY. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AS THE PATIENT HAD CARDIAC ARREST. ACTIONS TAKEN FOR THE PATIENT CONCERNING THE MEDICAL DEVICE: CLOSE MONITORING AND CONTINUOUS CARE ACTIONS TAKEN IN THE HOSPITAL: CHANGE OF THE

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7152005 ↗