Acquire M00555560Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729931805), received between Mar 13, 2017 and Nov 18, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS ATTEMPTED TO PULL THE STYLET AND SEVERE RESISTANCE WAS FELT WHILE PULLING THE STYLET OUT. THE DEVICE WAS FLUSHED WITH SALINE SOLUTION AFTER ONE SPECIMEN WAS COLLECTED, HOWEVER, A BLACK RUST-LIKE SUBSTANCE CAME OUT FROM THE TIP OF THE NEEDLE.THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828864 ↗
• MalfunctionOct 7, 2022Use of Device Problem; Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE MEDIASTINAL NODE DURING A FINE NEEDLE BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE COULD NOT PUNCTURE INTO THE NODE BECAUSE THE NODE WAS TOO SMALL. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE IS CURRENTLY NO DATE SET TO RESCHEDULE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567400 ↗
• MalfunctionMar 31, 2020Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNB NEEDLE WAS USED IN THE PANCREAS DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE NEEDLE TIP SEEMED TO BE VERY DULL, THEREFORE IT WAS REMOVED FROM THE SCOPE AND ANOTHER NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE EUS FNB NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE NEEDLE WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9905559 ↗
• InjuryMar 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREATIC BODY DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE BIOPSY WAS PERFORMED TRANSGRASTRICALLY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT INJURY. HOWEVER, POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A PANCREATIC CYST WHICH IS PROGRESSING TOWARDS RECOVERY DUE TO CONSERVATIVE TREATMENT. THE PATIENT'S CONDITION AFTER THE TREATMENT WAS REPORTED TO BE GOOD.

  Patient problems: Cyst(s); Fever

  MAUDE report 6400957 ↗