Acquire™ S M00555640Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00191506030742), received between Oct 9, 2024 and Jul 29, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific that an Acquire S EUS FNB was used to search for tumor in the pancreas during an Endoscopic Ultrasound and biopsy procedure performed on (b)(6) 2026.During the procedure, for the final puncture, the sheath came off the handle along with the needle at the moment it was inserted in the echoendoscope inside the patient. A Kelly forceps was required to remove it and an inspection with the echo endoscopic camera inside the patient confirmed that no piece or fragment remained. The procedure was completed without another device, as the doctor decided that the previous punctures were enough.The patient fully recovered following the procedure, and there were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073900 ↗
• MalfunctionMay 22, 2026Difficult to Advance; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ACQUIRE? S WAS INTENDED TO BE USED ON A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STYLET COULD NOT PASS BECAUSE IT INTERFERED WITH WHAT APPEARED TO BE A FOREIGN OBJECT. THE EVENT OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PATIENT DURING OR FOLLOWING THE PROCEDURE AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256618 ↗
• MalfunctionJan 15, 2026Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED IN THE HEAD OF PANCREAS DURING ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS STRONG RESISTANCE WHEN THE PHYSICIAN TRIED TO NEEDLING. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080732 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO ACQUIRE NEEDLES USED FOR SINGLE PATIENT DURING ONE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS TO BE USED IN THE LEVER DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE NEEDLE WAS DETACHED, AND THE SHEATH KNOB WAS BROKEN. 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 23854187 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO TWO OF THE TWO ACQUIRE? S NEEDLES USED FOR SINGLE PATIENT DURING ONE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ACQUIRE NEEDLE WAS TO BE USED IN THE LEVER DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE NEEDLE WAS DETACHED, AND THE SHEATH KNOB WAS BROKEN. 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 23851061 ↗
• MalfunctionJan 9, 2025Mechanical Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Integrity 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-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE TIP LENGTH WAS ADJUSTED AT THE TIME OF PUNCTURE AND THE HELIX WAS TIGHTENED TO PUNCTURE THE NEEDLE, BUT THE FORCE OF THE PUNCTURE CAUSED THE STOPPER TO SHIFT AND THE NEEDLE WAS PUNCTURED DEEPER THAN THE INTENDED TARGET SITE. THE BLOOD VESSEL WAS DAMAGED AND BLEEDING OCCURRED. THE PATIENT IS CURRENTLY UNDER OBSERVATION. WHEN THE RETRIEVED DEVICE WAS INSPECTED, TRACES OF THE STOPPER HAVING SHIFTED WAS FOUND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21118422 ↗
• InjuryOct 9, 2024Adverse 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 DUODENUM DURING AN ENDOSCOPIC ULTRASOUND BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. POST PROCEDURE ON (B)(6) 2024, THE PATIENT DEVELOPED A HEMATOMA AND WAS HOSPITALIZED BEYOND THE STANDARD OF CARE. A HEMATOMA EVACUATION WAS PERFORMED TO RESOLVE THE HEMATOMA. THE PATIENT WAS REPORTED TO BE DOING FINE AND IS OUT OF THE HOSPITAL.

  Patient problems: Hematoma

  MAUDE report 20413714 ↗
• InjuryOct 9, 2024Adverse 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 DUODENUM DURING AN ENDOSCOPIC ULTRASOUND BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. THE HEMATOMA RESOLVED ON ITS OWN WITHOUT TREATMENT, HOWEVER THE PATIENT WAS HOSPITALIZED OVERNIGHT BEYOND THE STANDARD OF CARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20413169 ↗
• InjuryOct 9, 2024Adverse 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 DUODENUM DURING AN ENDOSCOPIC ULTRASOUND BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. THE HEMATOMA RESOLVED ON ITS OWN WITHOUT TREATMENT, HOWEVER THE PATIENT WAS HOSPITALIZED OVERNIGHT BEYOND THE STANDARD OF CARE.

  Patient problems: Hematoma

  MAUDE report 20412829 ↗