Soehendra G22205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002222052), received between Jun 7, 2016 and Aug 28, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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.

• InjuryAug 28, 2018Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A SOEHENDRA STENT RETRIEVER. THE CUSTOMER LIKE TO DRILL THE PANCREAS DUCT AND THE TIP OF THE RETRIEVER GOT LOST [SIC]. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 08-AUGUST-2018: THE USER DILATED WITH THE STENT RETRIEVER. THEY TURNED THE RETRIEVER CLOCKWISE IN THE PANCREATIC DUCT. SURGERY IS AN OPTION TO REMOVE THE DETACHED TIP, BUT HAS NOT BEEN DONE YET. AN ATTEMPT WAS MADE TO RETRIEVE THE TIP, BUT WAS UNSUCCESSFUL. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION ON IF THE PATIENT REQUIRED SURGERY WERE UNSUCCESSFUL. IT IS CURRENTLY UNKNOWN IF SURGERY WAS REQUIRED, IF THE TIP OF THE DEVICE WAS LEFT TO PASS NATURALLY, OR THE IMPACT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7822898 ↗
• MalfunctionJun 7, 2016Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK SOEHENDRA STENT RETRIEVER. THE CUSTOMER REPORTED THAT THE CONNECTION THREAD OF THE STENT RETRIEVER DETACHED FROM CATHETER. DUE TO THIS, AN ADDITIONAL PROCEDURE HAD TO BE PERFORMED IN ORDER CORRECT THE FAULT AND REMOVE STENT. THE FOLLOWING WAS RECEIVED ON (B)(6) 2016 WITH THE COMPLAINT FORM: "THE PLAN WAS TO REMOVE THE PLASTIC STENT WITH THE STENT RETRIEVER AND PLACE A NEW STENT AFTERWARDS. WHEN THE STENT RETRIEVER WAS IN PLACE, THE FRONT PART DETACHED FROM THE CATHETER AND STAYED IN THE PLASTIC STENT. I WILL RETURN EVERYTHING, INCLUDING THE STENT. THEREFORE, THEY HAD TO TAKE A SNARE TO REMOVE THE STENT [AND THIS IS] WHAT CAUSED A LOSS OF THE WIRE POSITION [ANOTHER MANUFACTURER'S WIRE GUIDE]. IT WASN'T POSSIBLE TO PASS THE STRICTURE AGAIN, [WHICH IS] WHY A SPYGLASS PROCEDURE IS PLANNED."

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

  MAUDE report 5702985 ↗