Acquire M00555540Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729931782), received between Jun 14, 2019 and Jul 22, 2026 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908622 ↗
• MalfunctionJan 7, 2026Material Puncture/Hole; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY (EUS FNB) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE NEEDLE OF THE ACQUIRE WAS BENT. ANOTHER ACQUIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995893 ↗
• MalfunctionAug 15, 2025Entrapment of Device; Defective Device; Entrapment of Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING A FINE NEEDLE BIOPSY (FNB) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PRODUCT IS INCLUDED IN THE SCOPE AND DOES NOT FALL OUT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS 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 22813960 ↗
• MalfunctionMay 16, 2025Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING AN ECHO-ENDO PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS CANCELED WHILE USING THE DEVICE. DUE TO THIS EVENT, THE PATIENT'S HOSPITAL STAY WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039017 ↗
• MalfunctionJan 30, 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 ACQUIRE EUS FNA NEEDLE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN FROM THE SHEATHE HUB IN THE MIDDLE OF THE NEEDLE. THE MIDDLE PART OF THE NEEDLE COMPLETELY GOT BROKEN AND DETACHED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280067 ↗
• MalfunctionSep 9, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, ON THE SECOND ATTEMPT TO PERFORM BIOPSY, THE NEEDLE COULD NOT BE ADVANCED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER OF THE SAME DEVICE NO BEING AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20175498 ↗
• MalfunctionMay 10, 2024Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE ASPIRATION (EUS-FNA) PROCEDURE ON (B)(6) 2024. DURING WITHDRAWAL OF THE ACQUIRE NEEDLE, THE LUER ATTACHMENT WAS UNABLE TO UNLOCK FROM THE ENDOSCOPE. THE ENDOSCOPE ALONG WITH THE STUCK NEEDLE WERE REMOVED FROM THE PATIENT. THE SPECIMEN WAS COLLECTED FROM THE NEEDLE OF THE DEVICE. THE ENDOSCOPE WAS SENT FOR REPAIR TO REMOVE THE ACQUIRE NEEDLE. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287661 ↗
• MalfunctionApr 18, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SHEATH DID NOT COME OUT EVEN AFTER ADJUSTING THE SHEATH STOPPER. AFTER PUSHING FOR A WHILE, THE SHEATH CAME OUT AS IF IT WAS POPPING OUT, AND THE SAME MOVEMENT WAS OBSERVED WHEN ACQUIRE WAS PASSED THROUGH THE SCOPE OUTSIDE THE BODY. THE PROCEDURE WAS DISCONTINUED DUE TO THE POSSIBILITY OF A SCOPE MALFUNCTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133424 ↗
• MalfunctionMar 15, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PART OF THE DEVICE THAT CONTROLS THE NEEDLE DID NOT WORK. THE NEEDLE DID NOT MOVE AFTER INSERTION. THE SCOPE WAS REMOVED WITH THE NEEDLE. AS A RESULT, THE PROCEDURE HAS BEEN CANCELED DUE TO ANOTHER OF THE SAME DEVICE NOT BEING AVAILABLE. NO FURTHER INFORMATION OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912548 ↗
• InjuryNov 9, 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 ACQUIRE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) PERFORMED ON AN UNKNOWN DATE. POST-PROCEDURE, THE PATIENT DEVELOPED SEVERE PANCREATITIS. THE PATIENT IS CURRENTLY RECEIVING TREATMENT AS THE EVENT RESULTED IN PROLONGED HOSPITALIZATION. THERE WAS NO REPORTED MALFUNCTION OF THE ACQUIRE NEEDLE. IT IS UNKNOWN HOW THE PANCREATITIS IS BEING TREATED.

  Patient problems: Pancreatitis

  MAUDE report 18100285 ↗
• MalfunctionMar 24, 2023Mechanical Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE NEEDLE WAS DIFFICULT TO EXTEND AND RETRACT. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612994 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE DUODENAL BULB DURING AN ENDOSCOPIC ULTRASOUND FINE-NEEDLE BIOPSY (EUS-FNB) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE WOULD NOT EXTEND. THE PATIENT WAS SEDATED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149004 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE DUODENAL BULB DURING AN ENDOSCOPIC ULTRASOUND FINE-NEEDLE BIOPSY (EUS-FNB) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE WOULD NOT EXTEND. THE PATIENT WAS SEDATED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147948 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL TIP OF THE NEEDLE DETACHED INSIDE THE PATIENT AND WAS NOT REMOVED. REPORTEDLY, THE PHYSICIAN FOLLOWED UP WITH THE PATIENT AND THE PATIENT IS ASYMPTOMATIC. 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 13598877 ↗
• InjuryAug 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREAS TAIL DURING A TISSUE BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE NEEDLE WAS WITHDRAWN, THE TIP OF THE NEEDLE BROKE OFF AND REMAINED IN THE STOMACH. THE NEEDLE TIP WAS REMOVED FROM THE STOMACH WITH A SNARE AND A NEW ACQUIRE 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 12320783 ↗
• MalfunctionJul 2, 2021Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) PROCEDURE PERFORMED ON (B)(6) 2021. DURING WITHDRAWAL OF THE DEVICE, THE DEVICE COULD NOT BE REMOVED FROM THE ENDOSCOPE. THE ENDOSCOPE WAS REMOVED WITH THE DEVICE STILL INSIDE THE SCOPE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. AT THIS TIME, A NEW PROCEDURE HAS NOT BEEN SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112133 ↗
• MalfunctionJun 25, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  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 THE PROCEDURE, THERE WAS AN ISSUE WITH THE DEVICE, HOWEVER DETAIL ABOUT THE ISSUE ARE UNKNOWN. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197194 ↗
• DeathJun 14, 2019Adverse 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 DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY PROCEDURE PERFORMED IN THE PANCREAS ON (B)(6) 2019. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED THREE PASSES IN THE PANCREATIC HEAD WITH THE NEEDLE AND WAS ABLE TO OBTAIN ADEQUATE SAMPLE. THE BIOPSY PROCEDURE WAS COMPLETED USING THIS ACQUIRE NEEDLE. THERE WAS NO ALLEGED DEFICIENCY OF THE ACQUIRE NEEDLE REPORTED. POST PROCEDURE, THE PATIENT EXPERIENCED PAIN AND REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THE NEXT DAY, ON (B)(6) 2019 THE PATIENT WAS DIAGNOSED WITH PANCREATITIS. THE PHYSICIAN REPORTED THAT THE PANCREATITIS WAS LIKELY A RESULT OF THE BIOPSY THAT WAS PERFORMED. THE PHYSICIAN ALSO STATED THAT THE PATIENT HAD A HISTORY OF CHRONIC PANCREATITIS. THE PANCREATITIS REPORTEDLY GOT WORSE AND THE PATIENT WAS THEN PLACED ON A VENTILATOR. THE PATIENT THEN DEVELOPED RENAL FAILURE AND EXPIRED ON (B)(6) 2019. THE PHYSICIAN CONFIRMED THAT AUTOPSY RESULTS WILL NOT BE MADE AVAILABLE TO BOSTON SCIENTIFIC CORPORATION. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2019 DUE TO MULTIPLE ORGAN FAILURE.

  Patient problems: Death; Inflammation

  MAUDE report 8700092 ↗