Single Use Injector NM600/610 NM-610U-0523Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170377976), received between Oct 26, 2018 and Mar 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 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.

• MalfunctionMar 24, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY PROCEDURE, THE SURGEON EXPERIENCED "DIFFICULTY WITH THE NEEDLE INSERTING INTO THE BOWEL WALL. THEY HAVE HAD TO HAVE MULTIPLE TRIES TO GET THE NEEDLE TO ENTER THE MUCOSAL SO THAT THE INJECTATE COULD BE INSERTED - TWICE TO USE EVERLIFT TO RAISE THE POLYP AND ONCE FOR THE TATTOO TO MARK A BOWEL CANCER. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS EVENT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678700 ↗
• MalfunctionMar 24, 2025Difficult to Insert; Difficult to Insert

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678206 ↗
• MalfunctionMar 24, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY PROCEDURE, THE SURGEON EXPERIENCED "DIFFICULTY WITH THE NEEDLE INSERTING INTO THE BOWEL WALL. THEY HAVE HAD TO HAVE MULTIPLE TRIES TO GET THE NEEDLE TO ENTER THE MUCOSAL SO THAT THE INJECTATE COULD BE INSERTED - TWICE TO USE EVERLIFT TO RAISE THE POLYP AND ONCE FOR THE TATTOO TO MARK A BOWEL CANCER." THERE HAS BEEN NO REPORT OF ADVERSE EVENT/ HARM ASSOCIATED WITH THIS EVENT. THIS PROCEDURE WAS COMPLETED WITH A DEVICE OF AN UNKNOWN DEVICE OF A DIFFERENT MAKE/MODEL. THIS IS EVENT ONE OF THREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677851 ↗
• MalfunctionOct 26, 2018Break; Break

  DURING A COLONOSCOPY, THE SUBJECT DEVICE WAS USED. ALTHOUGH THE USER TRIED TO RETRACT THE NEEDLE OF THE SUBJECT DEVICE, THE NEEDLE COULD NOT BE RETRACTED INTO THE TUBE. THE INTENDED PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THIS IS THE REPORT REGARDING THE INABILITY TO RETRACT THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8007990 ↗