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Interject M00518160Recalls & reported problems

Boston Scientific Corporation · Injection Therapy Needle Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729415084), received between May 4, 2018 and May 4, 2018 — classified as 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

Device problems

  • Occlusion Within Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 4, 2018Occlusion Within Device; Occlusion Within Device

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR SCLEROTHERAPY WITH BLEEDING AT THE SPHINCTEROTOMY SITE PERFORMED IN (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE NEEDLE FOR EPINEPHRINE INJECTION DID NOT COME OUT ON THE FIRST OR SECOND TRY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7488604 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.