Roth Net Platinum 00715050 (UDI 00816765011973)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816765011973), received between Feb 14, 2018 and Jul 23, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Material Separation

  THE DISTRIBUTOR REPORTED THAT THE DISTAL LOOP OF A ROTH NET PLATINUM RETRIEVER BECAME DETACHED DURING PROCEDURAL USE TO RETRIEVE A POLYP IN THE CECUM. THE DETACHED PORTION OF THE DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITH NO REPORTED INJURY TO THE PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317312 ↗
• MalfunctionDec 11, 2019Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE WIRE LOOP OF A ROTH NET PLATINUM - UNIVERSAL BECAME PARTIALLY DETACHED DURING A FOOD BOLUS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTH NET DEVICE, AND THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9453211 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE MESH LOOP OF A ROTH NET PLATINUM RETRIEVER DETACHED FROM THE DEVICE DURING A PROCEDURE TO RETRIEVE GASTRIC POLYPS. THE PROCEDURE WAS COMPLETED USING A SECOND ROTH NET DEVICE, AND THE DETACHED PORTION WAS RETRIEVED. THERE WAS NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808260 ↗
• MalfunctionMay 8, 2019Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED THAT, DURING THE RETRIEVAL OF A POLYP, A PORTION OF THE CATHETER OF A ROTH NET DETACHED ON FIRST DEPLOYMENT OF THE DEVICE WITHIN THE PATIENT. RETRIEVAL OF THE POLYP WAS COMPLETED WITH A SECOND ROTH NET DEVICE AND THE DETACHED PORTION OF THE CATHETER WAS RETRIEVED. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8592811 ↗
• MalfunctionFeb 14, 2018Break; Detachment Of Device Component; Torn Material

  THE USER FACILITY REPORTED HANDLE DAMAGE AND TORN RETRIEVAL NETTING DURING USE OF MULTIPLE ROTH NET DEVICES FOR AN ESOPHAGEAL FOOD BOLUS PROCEDURE. ONE NET BECAME DETACHED FROM THE DEVICE AND WAS PUSHED WITH THE BOLUS INTO THE STOMACH. THE PATIENT DID NOT REQUIRE ANY FURTHER TREATMENT DUE TO THE NET BECOMING DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270924 ↗