Acquire M00555580Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729931829), received between Sep 17, 2019 and May 22, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Break; Mechanical Problem; Material Puncture/Hole; Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNB NEEDLE 19 G FLEX WAS USED FOR AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE NEEDLE WOULD NOT EXTEND OUT OF THE SHEATH. WHEN THE DEVICE WAS TRYING TO BE REMOVED FROM THE SCOPE, THE NEEDLE BROKE AND DETACHED FROM THE DEVICE. WHILE THE DEVICE WAS TAKING OUT OF THE SCOPE, THE NEEDLE CAUSED DAMAGED TO THE SCOPE AND PUNCTURED THE SHEATH. ANOTHER ACQUIRE EUS FNB NEEDLE 19 G FLEX WAS USED TO SUCCESSFULLY CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256608 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ACQUIRE EUS FNB NEEDLE 19G THROUGH THE ARTICLE: "PD04-2 TROUBLESHOOTING IN EUS-CDS," BY NOZOMI OKUNO, ET AL. PER THE ARTICLE, A RETROSPECTIVE STUDY INCLUDED 200 CASES OUT OF 237 CONSECUTIVE ATTEMPTS, WHERE ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS) PROCEDURES WERE PERFORMED AS THE PRIMARY DRAINAGE METHOD BETWEEN OCTOBER 2011 TO OCTOBER 2024. AMONG 174 PATIENTS DEEMED ELIGIBLE FOR EUS-CDS, EARLY COMPLICATIONS WERE OBSERVED IN 6.9% (12/174), INCLUDING PERITONITIS, ACUTE CHOLANGITIS, DOUBLE MUCOSAL PUNCTURE, ACUTE CHOLECYSTITIS, FEVER, AND BLEEDING. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

  Patient problems: Cholangitis; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation; Perforation; Peritonitis

  MAUDE report 22470562 ↗
• MalfunctionOct 3, 2024Detachment 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 ACQUIRE EUS FNB NEEDLE WAS USED IN THE LIVER DURING AN EUS GUIDED LIVER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE NEEDLE WAS NOT MOVING IN CONJUNCTION WITH THE HANDLE. UPON RETRACTING THE NEEDLE, IT WAS FOUND THAT THE NEEDLE HAS DETACHED FROM THE HANDLE. THE SAME PROBLEM WAS OBSERVED WHEN THE DEVICE WAS INSPECTED OUTSIDE OF THE PATIENT. A VIDEO WAS PROVIDED WHICH SHOWS THE DEVICE WAS INSPECTED OUTSIDE OF THE PATIENT AND THE NEEDLE WAS FOUND DETACHED INSIDE THE WORKING LENGTH. NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. ANOTHER NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360602 ↗
• MalfunctionNov 8, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE LIVER DURING AN ENDOSCOPIC ULTRASOUND-GUIDED LIVER BIOPSY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE DID NOT EXTEND. IT WAS FOUND THAT THE NEEDLE WAS DISENGAGED FROM THE HANDLE. ADDITIONALLY, IT WAS CONFIRMED THAT THE DISTAL NEEDLE TIP DETACHED FROM THE DEVICE, HOWEVER THE TIP DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 18094747 ↗
• MalfunctionSep 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE LIVER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE WAS FLUSHED WITH HEPARIN PRIOR TO INSERTION FOR LIVER BIOPSY. THE TECHNICIAN NOTICED BLACK MATERIALS FLUSHING OUT FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING 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 17794336 ↗
• MalfunctionSep 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE BILIARY TREE DURING A LIVER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN WAS PUSHING THE NEEDLE CATHETER AND FELT RESISTANCE. A PIECE OF CLEAR PLASTIC WITH THE WORDS "STERILE" ON IT POPPED OUT OF THE WORKING CHANNEL OF THE SCOPE. THEY TOOK THE NEEDLE OUT OF THE SCOPE AND GRABBED THE PLASTIC USING FORCEPS. IT IS UNCLEAR IF THE PLASTIC CAME FROM THE SCOPE OR THE NEEDLE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341538 ↗
• MalfunctionAug 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIE EUS FNB NEEDLE WAS USED DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING REMOVAL OF THE NEEDLE, THE TIP OF THE NEEDLE SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIE EUS FNB NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381405 ↗
• MalfunctionMar 4, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNB NEEDLE WAS USED DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THEY FLUSHED THE NEEDLE WITH SALINE BEFORE INTRODUCING IT TO THE PATIENT. DURING THE FLUSH, THEY NOTICED THERE WERE BLACK REMNANTS THAT CAME OUT FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE EUS FNB NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785172 ↗
• MalfunctionDec 2, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN LYMPH NODES DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE ASPIRATION (EUS-FNA) PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, WHILE PERFORMING PUNCTURE DURING THE PROCEDURE, RESISTANCE WAS MET WHEN SLIGHTLY PULLING OUT THE STYLET PART OF THE INNER CATHETER. THE DISTAL TIP OF THE NEEDLE WAS FOUND TO BE BENT/BROKEN. IT WAS CONFIRMED THAT THE DISTAL TIP HAD BROKEN/DETACHED BUT REMAINED INSIDE THE CATHETER OF THE DEVICE AND THEREFORE DID NOT FALL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL ACQUIRE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398672 ↗
• MalfunctionSep 17, 2019Detachment 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 ACQUIRE NEEDLE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE NEEDLE BROKE DURING PROCEDURE WHILE TRYING TO GET A SPECIMEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE, AT THE CONCLUSION OF THE PROCEDURE. 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 9078791 ↗