Zebra M0066701100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729752769), received between Oct 24, 2017 and Nov 8, 2023 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• DeathNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE "A DOUBLE-J STENT MISGUIDED BY ZEBRA GUIDEWIRE INTO ILEUM: A CASE REPORT AND LITERATURE REVIEW", BY LIANGCHENG LIU, GUIHUA CAO, GUIMIN HUANG, JIANPING DU, WEI LI, QIANG LI. ACCORDING TO THE ARTICLE, THE PATIENT HAD A LAPAROSCOPIC LEFT NEPHRO-URETERECTOMY AND CONTRALATERAL END CUTANEOUS URETEROSTOMY, WITH REGULAR DOUBLE-J STENTING EVERY 3 MONTHS FOR THE PATIENT'S STOMAL STENOSIS. THREE MONTHS AFTER THE SURGERY THE PATIENT UNINTENTIONALLY PULLED OUT THEIR DOUBLE-J STENT AND A ZEBRA GUIDEWIRE WAS USED TO REPLACE THE DOUBLE J-STENT AROUND OCTOBER 2011. FOLLOWING THE STENT PLACEMENT, WHILE THE PATIENT WAS UNDER OBSERVATION, IT WAS NOTED THAT THERE WAS NO DRAINAGE FLUID IN THE PATIENT'S OSTOMY BAG FOR 12 HOURS, AND THE DOUBLE-J STENT DISAPPEARED IN THE ABDOMINAL WALL. AN ABDOMINAL PELVIC CT WAS PERFORMED AND IT WAS FOUND THAT THERE WAS HYDRONEPHROSIS IN THE RIGHT KIDNEY AND THE STENT WAS LOCATED IN THE ILEUM. THE PATIENT WAS GIVEN GASTROINTESTINAL MOTILITY DRUG AND THEN THE STENT WAS EXCRETED WITH THE FECES AFTER 12 HOURS. THREE DAYS LATER, THE PATIENT'S SCR ROSE TO 432.7MICROMOL/L, AND URETEROSCOPY WAS

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Perforation; Septic Shock; Unspecified Infection

  MAUDE report 18094132 ↗
• InjuryJul 24, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A ZEBRA GUIDEWIRE WAS USED IN THE URETER DURING URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE ZEBRA GUIDEWIRE WAS TOUGH AND POINTED, INDICATING THAT THE CORE WIRE BROKE. AFTER SEVERAL INSERTION, THE URETERAL MUCOSA WAS PERFORATED, WHICH CREATED A FALSE PATH. REPORTEDLY, THE URETERAL MUCOSA WAS DAMAGED AND BLEEDING NOTED DURING THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT, HE COULD NOT CONFIRM WHETHER THE ZEBRA CAUSED OR CONTRIBUTED TO THE PERFORATION OF THE URETER, INCLUDING THE DAMAGED URETERAL MUCOSA, AND BLEEDING. THERE WAS NO INTERVENTION PERFORMED TO ADDRESS THE PERFORATION AND BLEEDING. THE PROCEDURE WAS COMPLETED WITH A SECOND ZEBRA GUIDEWIRE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 8823146 ↗
• MalfunctionOct 24, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZEBRA¿ GUIDEWIRE WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WAS KINKED AND THE CORE WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NEW ZEBRA¿ GUIDEWIRE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6970898 ↗