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Interject M00518360Recalls & reported problems

Boston Scientific Corporation · Injection Therapy Needle Catheter · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729415121), received between Jun 6, 2018 and Mar 17, 2023 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Contaminated During Manufacture or Shipping1
  • Occlusion Within Device1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT SCLEROTHERAPY NEEDLE WAS TO BE USED IN A PROCEDURE ON (B)(6), 2023. PRIOR TO THE PROCEDURE, BEFORE OPENING THE PACKAGE, A FOREIGN MATERIAL WAS NOTED IN THE SEALED PACKAGING. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16562878 ↗
  • MalfunctionAug 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THEY WERE PULLING THE INJECTOR NEEDLE OUT OF THE SCOPE, THE NEEDLE ITSELF FELL OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT 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 7799673 ↗
  • MalfunctionJun 6, 2018Occlusion Within Device; Occlusion Within Device

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS UNABLE TO PUSH SALINE THROUGH THE CATHETER. THE NEEDLE WAS REMOVED FROM THE SCOPE AND STILL COULD NOT PUSH ANY SALINE THROUGH THE CATHETER. THE LUER LOCK SYRINGE WAS REMOVED FROM THE CATHETER AND PUT BACK ON, AND STILL NO SALINE COULD BE PUSHED THROUGH. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7576032 ↗

Other Biopsy needle devices

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