Interject M00518150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729415077), received between Feb 15, 2017 and Jun 6, 2023 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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. How this data works · Data updated Oct 13, 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.

• DeathJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE ESOPHAGUS DURING A PERORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF ACHALASIA. DURING THE PROCEDURE, THE PATIENT BEGAN TO PRESENT LOW VITALS INCLUDING LOW BLOOD PRESSURE AND DECREASED PULSE. IT WAS REPORTED THAT THEY PERFORMED CPR FOR AROUND 20 MINUTES AND THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT WHERE AT SOME POINT THEY PASSED AWAY. THE PHYSICIANS PRESENT WERE ABLE TO CONFIRM THAT DUE TO ANESTHESIA ERROR, THE PATIENT DID NOT HAVE ACCESS TO ANESTHESIA MACHINE VENTILATION, AS THE VENTILATION TUBE WAS BENT. IN THE PHYSICIAN'S ASSESSMENT, THE INTERJECT NEEDLE DEVICE WAS USED CORRECTLY AND DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. IT WAS CONFIRMED THAT ANESTHESIOLOGY ERROR WAS THE CAUSE OF DEATH. THERE WAS NO ALLEGED MALFUNCTION OF THE INTERJECT NEEDLE.

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 17076034 ↗
• MalfunctionFeb 15, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE ASCENDING COLON DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE NEEDLE WAS BLOCKED/OCCLUDED AND THEY WERE UNABLE TO INJECT ANY CONTRAST DYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ SCLEROTHERAPY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6332210 ↗