Interject M00518300Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729376194), received between Feb 15, 2017 and Feb 13, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT SCLEROTHERAPY NEEDLE WAS USED IN THE INTESTINES FOR COLONIC MASS DURING A DISSECTION OF INTESTINAL LESION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE OUTER SHEATH WAS FRACTURED WHEN THE INJECTION NEEDLE WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 1, 2026: IT WAS LATER CONFIRMED THAT THE NEEDLE PUNCTURED OR PROTRUDED THE CATHETER, CAUSING THE CATHETER TO GET FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337857 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED DURING A GASTRIC VARICES PROCEDURE PERFORMED ON (B)(6) 2025. UPON UNPACKING, THE NEEDLE WAS BROKEN AND DETACHED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, IT WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582291 ↗
• MalfunctionApr 25, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS TO BE USED IN THE COLON FOR AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN REMOVING THE DEVICE FROM THE PACKAGING BOX, IT WAS OBSERVED THAT THE STERILE SEAL WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19178514 ↗
• MalfunctionFeb 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS INTENDED TO BE USED DURING A PROCEDURE ON AN UNKNOWN DATE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE DEVICE CONTAINED ONE HAIR INSIDE THE STERILE PACKAGING. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THIS TIME, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405844 ↗
• MalfunctionNov 19, 2021Detachment 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 POLYPS PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE OUTER SHEATH FELL OFF AT THE DISTAL TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847413 ↗
• MalfunctionJul 2, 2021Detachment 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 STOMACH DURING A TISSUE RESECTION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE WAS HALVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112096 ↗
• MalfunctionJun 22, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS OPENED ON (B)(6) 2021. DURING PREPARATION, THE PHYSICIAN FOUND HAIR CONTAMINATION. IT WAS REPORTED THAT THE DEVICE WAS NOT UNPACKED. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044305 ↗
• MalfunctionApr 19, 2021Detachment 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 DUODENUM DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THE PHYSICIAN UNPACKED THE NEEDLE, THE TIP OF THE NEEDLE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690681 ↗
• MalfunctionApr 12, 2021Detachment 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 ESOPHAGEAL VEIN DURING AN INJECTION OF ESOPHAGEAL VARICEAL SCLEROSING AGENT PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE CATHETER WHEN THE DEVICE WAS OUTSIDE OF THE PATIENT. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649941 ↗
• MalfunctionMar 30, 2021Detachment 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 SMALL INTESTINE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE DETACHED IN TWO PIECES. THE DEVICE WAS REMOVED FROM THE PATIENT AND 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592589 ↗
• MalfunctionNov 9, 2020Detachment 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 STOMACH DURING AN GASTRIC FUNDUS VARICOSE VEINS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN UNPACKED THE DEVICE AND FOUND THAT THE NEEDLE FELL OFF. 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 10813310 ↗
• MalfunctionDec 12, 2019Break; Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem; Break; Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A INTERJECT CLEAR NEEDLE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THEY NOTICED THAT THE NEEDLE WAS COMPLETELY OUT OF THE SHEET AND THEREFORE THE STERILE BARRIER OF THE PACKAGING WAS COMPROMISED. IT WAS ALSO NOTED THAT THE NEEDLE WAS PREMATURELY EXTENDED, AND THE HANDLE OF THE DEVICE WAS BROKEN, UPON REMOVING FROM THE PACKAGE. 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 9457763 ↗
• MalfunctionJun 7, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE GASTROINTESTINAL DURING AN ELECTROSTATIC DISCHARGE (ESD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, SALINE COULD NOT BE INJECTED INTO THE POLYPS. THE NEEDLE WAS BLOCKED. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580585 ↗
• MalfunctionNov 20, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS BLOCKED AND COULD NOT INJECT. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046494 ↗
• MalfunctionFeb 15, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT CLEAR NEEDLE WAS USED IN THE COLON DURING A COLON ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS BLOCKED/OCCLUDED. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6331616 ↗