Jagwire™ Revolution M00557020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729962427), received between Jan 21, 2020 and Apr 17, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CBD STONE REMOVAL PROCEDURE TO JAUNDICE AND CBD STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE STONE WAS CAPTURED, THE BASKET COULD NOT BE PULLED THROUGH THE PAPILLA. THE TRAPEZOID RX BASKET WAS THEN CONNECTED TO AN ALLIANCE HANDLE TO PERFORM LITHOTRIPSY. DURING LITHOTRIPSY, THE BASKET FRACTURED AT THE HANDLE END, AND THE SAFETY RELEASE MECHANISM DID NOT ACTIVATE TO ALLOW RELEASE OF THE STONE FROM THE BASKET. THE PHYSICIAN THEN PERFORMED ANOTHER CRE DILATION, BUT THE CRE BALLOON DEVELOPED A SMALL RUPTURE DURING INFLATION. FOLLOWING THE RUPTURE OF THE CRE BALLOON, THE PHYSICIAN ATTEMPTED A PARTIAL PAPILLOTOMY USING A TRUETOME. HOWEVER, THE CUTTING EFFICIENCY WAS POOR, POSSIBLY DUE TO INTERFERENCE FROM A CBD STONE OR THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918042 ↗
• InjuryNov 15, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS TRANSFERRED TO THIS HOSPITAL FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDANCE AFTER UNSUCCESSFUL ERCP AT AN OUTSIDE HOSPITAL. THE PROCEDURE DATE IS UNKNOWN. PATIENT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDANCE AND LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE AND DISCHARGED ON POSTOPERATIVE DAY FOUR. IT WAS REPORTED THE FOLLOWING DEVICES WERE USED IN THE PROCEDURE TWO JAGWIRE REVOLUTION GUIDEWIRES ONE .025 AND ONE .035, ANOTHER NON-BSC GUIDEWIRE, AND A NON-BSC SINGLE USE 3 LUMEN SPHINCTEROTOME. POST PROCEDURE, ON (B)(6) 2022, TWO DAYS AFTER DISCHARGE, PATIENT RETURNED TO THE EMERGENCY ROOM AND CT SCAN SHOWED A FOREIGN BODY IN THE RIGHT UPPER QUADRANT CONSISTENT WITH PIECE OF RETAINED WIRE. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY WITH EXPLORATORY LAPAROTOMY FOR REMOVAL OF FOREIGN BODY. PATIENT WAS DISCHARGED HOME TWO DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801739 ↗
• MalfunctionApr 25, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS INSERTED THROUGH A NON-BOSTON SCIENTIFIC EUS NEEDLE, IT WAS NOT ABLE TO PASS THE INTRAHEPATIC BILIARY TREE DISTALLY. THE GUIDEWIRE COREWIRE BROKE. IT WAS REPORTED THAT A SECTION OF THE GUIDEWIRE WAS RETAINED WITHIN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14197343 ↗
• MalfunctionNov 11, 2020Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE REVOLUTION GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, JAGWIRE REVOLUTION GUIDEWIRE WAS ADVANCED THROUGH THE WORKING CHANNEL OF SPHINCTEROTOME AND AS THE TECHNICIAN WAS MANIPULATING THE WIRE THROUGH AMPULLA THE GUIDEWIRE COATING PEELED OFF AND COREWIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MANUFACTURERS GUIDEWIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822185 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II, SPYBITE, AND JAGWIRE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2020-00067, 3005099803-2020-00069 AND 3005099803-2020-00068 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II, SPYBITE, JAGWIRE REVOLUTION AND A NON-BSC SPHINCTEROTOME WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT SUFFERED AN AIR EMBOLISM WHICH WAS SUSPECTED TO BE CAUSED BY A PERFORATION. THE PHYSICIAN COULD NOT CONFIRM IF THE PERFORATION WAS RELATED TO THE SPYSCOPE, SPYBITE, GUIDEWIRE, OR NON-BSC SPHINCTEROTOME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE PERFORATION TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Air Embolism; Perforation

  MAUDE report 9610259 ↗