Soehendra G21661Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002216617), received between Sep 26, 2017 and Nov 4, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Material Fragmentation; Material Fragmentation

  DURING ATTEMPT OF STENT REMOVAL, THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. IT WAS REPORTED THAT AN ENDOSCOPE WAS INSERTED THROUGH THE MOUTH, AND A WIRE GUIDE WAS INSERTED INTO THE 8.5FR STENT PROTRUDING FROM THE PAPILLA. AFTER THE WIRE GUIDE WAS PLACED INTO THE STENT TO BE RETRIEVED, THE ERCP CANNULA WAS REMOVED AND THE SSR-8.5 WAS INSERTED INTO THE STENT OVER THE WIRE GUIDE. WHILE TURNING THE SSR-8.5 CLOCKWISE INSIDE THE STENT, THE THREADED END CAME OFF. NO PARTICULAR RESISTANCE WAS FELT WHEN THE SCREW CAME OFF. THE REMOVED THREADED END WAS RETRIEVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE USING AN IDENTICAL PRODUCT (LOT UNKNOWN) FROM THE HOSPITAL'S INVENTORY. 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 23464936 ↗
• MalfunctionDec 6, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. THE STENT RETRIEVER TIP CAME AWAY INSIDE THE PATIENT [DETACHED]. THE LOCATION OF THE DETACHED PORTION IS UNKNOWN. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9432890 ↗
• MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A STENT REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. DURING USE, THE TIP OF THE STENT RETRIEVER FELL OFF AND STAYED IN THE SMALL INTESTINE TO BE EXCRETED. THE TIP WAS NOT RETRIEVED. THE STENT WAS RETRIEVED VIA THE WIRE GUIDE USED TO INTRODUCE THE NEW STENT. THE DETACHED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9158477 ↗
• InjurySep 26, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. STENT REPLACEMENT WAS BEING PERFORMED. TO RETRIEVE THE PLACED PLASTIC STENT, THE USER ADVANCED THE SOEHENDRA STENT RETRIEVER OVER THE WIRE GUIDE THROUGH THE DUODENOSCOPE. THEN, THE TIP OF THE DEVICE WAS SCREWED INTO THE PLACED STENT LUMEN. HOWEVER, THE TIP OF THE STENT RETRIEVER BROKE OFF. THE DEVICE BODY AND THE WIRE GUIDE WERE REMOVED FROM THE PATIENT'S BODY WITH THE SEPARATED TIP REMAINING INSIDE DUODENUM. ANOTHER SOEHENDRA STENT RETRIEVER WAS USED TO RETRIEVE THE STENT, AND ANOTHER STENT WAS PLACED. AFTER THIS, THE USER RETRIEVED THE SEPARATED TIP FROM DUODENUM TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6895372 ↗