Interject M00518350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729415114), received between Nov 14, 2016 and Apr 12, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem; Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS RECEIVED AND A HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT. 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 Patient Involvement

  MAUDE report 8511583 ↗
• MalfunctionJun 11, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT SCLEROTHERAPY NEEDLE WAS USED IN THE STOMACH DURING A HEMOSTASTIS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS OCCLUDED. REPORTEDLY THE SUBSTANCE THEY WERE TRYING TO INJECT WAS DILUTED EPINEPHRINE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7587870 ↗
• MalfunctionDec 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE ESOPHAGUS/STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BOTOX INJECTION PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WOULD NOT DELIVER THE INJECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 7148910 ↗
• MalfunctionNov 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS UNPACKED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING A FOREIGN MATTER WAS NOTED INSIDE THE STERILE POUCH. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7016100 ↗
• MalfunctionJun 26, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT SCLEROTHERAPY NEEDLE WAS USED DURING A PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE NEEDLE WAS BENT. 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 STABLE. 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 Consequences Or Impact To Patient

  MAUDE report 6668698 ↗
• MalfunctionNov 14, 2016Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT SCLEROTHERAPY NEEDLE WAS USED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE TREATING A BLEED IN THE AMPULLA, THE NEEDLE WOULD NOT ADVANCE OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 STABLE. THE INVESTIGATION FOUND THAT THE NEEDLE HAD PUNCTURED THROUGH THE SHEATH. THIS IS DEEMED AS AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6099136 ↗