Fusion G48277Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002482777), received between May 19, 2017 and May 19, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 22, 2023Open, Classified

   Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

   Z-2252-2023 · Root cause: Process control · FDA record ↗

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.

• MalfunctionMay 19, 2017Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR TESTING, THE USER SELECTED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. AT THE TESTING, THE CABLE IN THE CATHETER GOT TORN APART. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 5/12/17: THE CABLE RIPPED IN THE CATHETER INSTEAD OF AT THE TIP. WE PUT A PEN TO SIMULATE THE STONE IN THE BASKET AND PUT THE HANDLE IN THE ALLIANCE HANDPUMP FROM BOSTON SCIENTIFIC AND CLOSED THE BASKET. AFTER WE CUT OFF THE HANDLE AND INSERTED THE CABLE INTO THE COOK CONQUEST TTC AND SOEHENDRA LITHOTRIPTOR HANDLE THE CABLE RIPPED INSIDE THE CATHETER INSTEAD OF AT THE TIP. PER A TELECONFERENCE ON 5/15/2017 WITH THE AREA REPRESENTATIVES THE USER WAS "UNDER THE IMPRESSION THAT THE BASKET WOULD BREAK AT THE TIP DURING MECHANICAL LITHOTRIPSY". THE PRODUCT WAS USED PRIOR TO USE IN A TEACHING ENVIRONMENT TO SHOW THE USER WHAT THE PRODUCT WOULD DO WITH A PEN TO SIMULATE THE STONE IN THE BASKET. DURING THE DISCUSSION IT WAS DISCLOSED THAT "THE SOEHENDRA LITHOTRIPTOR HANDLE WAS CRANKED PRETTY FAST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578056 ↗
• MalfunctionMay 19, 2017Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR TESTING, THE USER SELECTED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. AT THE TESTING, THE CABLE IN THE CATHETER GOT TORN APART. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 5/12/17: THE CABLE RIPPED IN THE CATHETER INSTEAD OF AT THE TIP. WE PUT A PEN TO SIMULATE THE STONE IN THE BASKET AND PUT THE HANDLE IN THE ALLIANCE HAND PUMP FROM BOSTON SCIENTIFIC AND CLOSED THE BASKET. AFTER WE CUT OFF THE HANDLE AND INSERTED THE CABLE INTO THE COOK CONQUEST TTC AND SOEHENDRA LITHOTRIPTOR HANDLE THE CABLE RIPPED INSIDE THE CATHETER INSTEAD OF AT THE TIP. PER A TELECONFERENCE ON 5/15/2017 WITH THE AREA REPRESENTATIVES THE USER WAS "UNDER THE IMPRESSION THAT THE BASKET WOULD BREAK AT THE TIP DURING MECHANICAL LITHOTRIPSY." THE PRODUCT WAS USED PRIOR TO USE IN A TEACHING ENVIRONMENT TO SHOW THE USER WHAT THE PRODUCT WOULD DO WITH A PEN TO SIMULATE THE STONE IN THE BASKET. DURING THE DISCUSSION IT WAS DISCLOSED THAT "THE SOEHENDRA LITHOTRIPTOR HANDLE WAS CRANKED PRETTY FAST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578055 ↗
• MalfunctionMay 19, 2017Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR TESTING, THE USER SELECTED TWO (2) COOK FUSION LITHOTRIPSY EXTRACTION BASKETS. AT THE TESTING, THE CABLE IN THE CATHETERS GOT TORN APART. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 5/12/2017: THE CABLE RIPPED IN THE CATHETER INSTEAD OF AT THE TIP. WE PUT A PEN TO SIMULATE THE STONE IN THE BASKET AND PUT THE HANDLE IN THE ALLIANCE HAND PUMP FROM BOSTON SCIENTIFIC AND CLOSED THE BASKET. AFTER WE CUT OFF THE HANDLE AND INSERTED THE CABLE INTO THE COOK CONQUEST TTC AND SOEHENDRA LITHOTRIPTOR HANDLE THE CABLE RIPPED INSIDE THE CATHETER INSTEAD OF AT THE TIP. PER A TELECONFERENCE ON (B)(6) 2017 WITH THE AREA REPRESENTATIVES THE USER WAS "UNDER THE IMPRESSION THAT THE BASKET WOULD BREAK AT THE TIP DURING MECHANICAL LITHOTRIPSY." THE PRODUCT WAS USED PRIOR TO USE IN A TEACHING ENVIRONMENT TO SHOW THE USER WHAT THE PRODUCT WOULD DO WITH A PEN TO SIMULATE THE STONE IN THE BASKET. DURING THE DISCUSSION, IT WAS DISCLOSED THAT "THE SOEHENDRA LITHOTRIPTOR HANDLE WAS CRANKED PRETTY FAST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578049 ↗