InterjectRecalls & reported problems across all models

We found 9 models of Interject by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Feb 13, 2026 — classified as 1 death, 101 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (81 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Interject problems

Interject models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Interject M00518250

  Biopsy needle
  70 reports
• Interject M00518300

  Biopsy needle
  15 reports
• Interject M00518350

  Biopsy needle
  6 reports
• Interject M00518310

  Biopsy needle
  3 reports
• Interject M00518360

  Biopsy needle
  3 reports
• Interject M00518150

  Biopsy needle
  1 death2 reports
• Interject M00518100

  Biopsy needle
  1 report
• Interject M00518160

  Biopsy needle
  1 report
• Interject M00518260

  Biopsy needle
  1 report

Recent Interject adverse event reports

The 15 most recent reports across all models, 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 24, 2025Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE COLON DURING PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE PUNCTURED THE SHEATH AND THE WORKING LENGTH WAS DETACHED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632625 ↗
• 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 ↗
• MalfunctionMay 27, 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 IN THE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SHEATH. ANOTHER INTERJECT NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088046 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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