Soehendra G21937Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002219373), received between Aug 15, 2016 and Mar 29, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. SUDDENLY, THE TIP OF THE RETRIEVER GOT LOST [DETACHED].

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7383406 ↗
• InjuryAug 15, 2016Fracture; Off-Label Use; Fracture; Off-Label Use

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. THE FOLLOWING WAS REPORTED TO COOK: "THE SOEHENDRA STENT RETRIEVER (SSR) WAS USED FOR THE PURPOSE OF PASSING THROUGH THE BILE DUCT BECAUSE A CANNULA WOULD NOT PASS THROUGH THE HEPATIC PORTAL REGION DUE TO A STONE. THE USER INSERTED THE SSR OVER A WIRE GUIDE AND ATTEMPTED TO PASS THE SIDE OF THE STONE BY ROTATING THE SSR AS GRINDING THE STONE WITH THE TIP OF THE SSR. HOWEVER, THE SSR WOULD NOT PASS THROUGH THE SIDE OF THE STONE, SO THE USER GAVE UP ON THE SSR AND REMOVED IT. AND THEN HE INSERTED A BASKET CATHETER AND FOUND THE TIP OF SSR (THREADED PART) WAS DETACHED/BROKEN OFF AND REMAINED THERE WHEN HE REACHED THE BASKET CATHETER TO THE LOCATION OF THE STONE. HE ACCIDENTALLY PUSHED THE BROKEN TIP BEYOND THE STONE WITH THE BASKET CATHETER AND REMOVAL OF THE BROKEN TIP BECAME DIFFICULT. SO HE ENDED THE PROCEDURE WITH THE BROKEN TIP REMAINING IN THE PATIENT'S BODY. REMOVAL OF THE BROKEN TIP WILL BE PERFORMED SOMETIME THIS WEEK." ON 07/29/2016, WE RECEIVED THE FOLLOWING UPDATE: "THE PATIENT HAS NOT SHOWN ANY PROBLEMATIC SYMPTOMS DUE TO THIS OCCURRENCE AS OF TODAY (B)(6). INTERVENTION TO REMOVE THE DETA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5875514 ↗