Fusion G48278Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002482784), received between May 19, 2017 and Jun 17, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (2 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-2253-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Split, Cut or Torn

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE COMMON BILE DUCT STONES, THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. IT WAS REPORTED THAT THERE WAS AN IMPACTED STONE, SO THEY DECIDED TO USE A COOK FUSION BASKET TO REMOVE IT. THIS THEN GOT IMPACTED AND THEY USED THE EMERGENCY LITHOTRIPTER TO REMOVE IT BUT UNFORTUNATELY THIS FRACTURED AND THEY WERE UNABLE TO REMOVE IT. THE PATIENT THEN HAD TO GO FOR EMERGENCY SURGERY TO REMOVE THE BASKET.

  Patient problems: Foreign Body In Patient

  MAUDE report 25537356 ↗
• MalfunctionMay 8, 2026Sharp Edges

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE BASKET WILL NOT PASS THROUGH THE CHANNEL AT ALL, UPON REMOVING THE BASKET IT LOOKED LIKE THERE WAS EXTRA MATERIAL ON THE SIDE OF THE CATHETER. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE RETURNED ON (B)(6) 2026 AND THE ORANGE WIRE GUIDE CHANNEL WAS DAMAGED AT THE PATIENT END [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125770 ↗
• MalfunctionJan 9, 2026Sharp Edges

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) LITHOTRIPSY, THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. IT WAS REPORTED THAT DURING ADVANCEMENT THROUGH THE SCOPE THE WIRE GUIDE LUMEN WAS DETECTED TO BE DAMAGED. THE USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028286 ↗
• MalfunctionJun 11, 2019Entrapment of Device; Entrapment of Device

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET (FS-LXB-3X6). THE STONES COULD NOT BE BROKEN IN BASKET LOCALIZATION AND HANDLING PROVED VERY DIFFICULT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: FIRST, THE CUSTOMER TRIED TO CRUSH THE STONE WITH THE FS-LXB-3X6 ALONE. THEN, THEY PUT THE HANDLE [OF THE BASKET] INTO THE ANOTHER MANUFACTURER'S HANDLE WITHOUT SUCCESS IN BREAKING THE STONE. IN THE NEXT STEP, THEY REMOVED THE HANDLE AND THE SHEATH OF THE BASKET, PUT ON ANOTHER MANUFACTURES' CABLE AND USED ANOTHER MANUFACTURER'S HANDLE TO CRUSH THE STONE, AGAIN WITHOUT SUCCESS. THEY INTRODUCED A GASTROSCOPE PARALLEL TO THE BASKET AND REMOVED THE WIRES OF THE BASKET ONE BY ONE SO THEY COULD GET THE BASKET OUT. THE FOLLOWING DAY THEY USED AN ELECTROHYDRAULIC PROBE TO CRUSH THE STONE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THE GALLBLADDER WAS PERFORATED BY THE STONE ITSELF. IT GOT TOO BIG TO BE HELD BY THE GALLBLADDER. THE SITUATION WAS THAT THE STONE CREATED A CLOSURE OF THE DUODENUM BECAUSE OF ITS SIZE. IT WAS COMPLETELY STUCK IN THE DUODENUM. THE STONE EXTRACTION / LITHOTRIPSY WAS PLANNED FROM THE DUODENUM. T

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 8688489 ↗
• InjuryJan 10, 2019Fracture; Fracture

  DURING A LITHOTRIPSY PROCEDURE, THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. AN EXTRACTION [OF STONES WAS ATTEMPTED] WITH THE BASKET. A DISTANT LEARNING [SIC] WAS NOT POSSIBLE WITHOUT LITHOTRIPSY. THE LITHOTRIPSY EXTRACTION BASKET HANDLE [WAS LOADED] INTO THE ALLIANCE HANDLE. A SLOW ATTEMPT TO SHRED THE STONE [WAS MADE]. THE LITHOTRIPSY EXTRACTION BASKET WAS TORN BY THE HAND [HANDLE]. EMERGENCY LITHOTRIPSY WAS NOT POSSIBLE. SURGERY WAS PERFORMED TO REMOVE THE STONES AND THE LITHOTRIPSY EXTRACTION BASKET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED SURGERY TO REMOVE THE STONES AND BASKET DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8236278 ↗
• MalfunctionAug 24, 2017Split; Split

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. AS REPORTED TO CUSTOMER RELATIONS: "THE BASKET WAS ADVANCED OVER THE GUIDE WIRE AND DOWN THE ENDOSCOPE. WHEN THE BASKET BEGAN TO EXIT THE ENDOSCOPE, THE PHYSICIAN NOTICED THE ANGLE OF THE BASKET WAS INCORRECT. THE BASKET WAS THEN REMOVED AND INSPECTED. IT WAS THEN DISCOVERED THAT THE GUIDE WIRE HAD RIPPED THROUGH THE ORANGE SHEATH."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6817790 ↗
• 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 6578054 ↗