AcquireRecalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of Acquire by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2017 and Jul 22, 2026 — classified as 1 death, 4 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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
Reports received per month, all models
Most reported Acquire problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Detachment of Device or Device Component11
- Mechanical Problem6
- Device Contamination with Chemical or Other Material4
- Defective Device3
- Difficult to Remove3
- Activation, Positioning or Separation Problem2
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient6
- Fever2
- Inflammation2
- Cholangitis1
- Cyst(s)1
- Death1
- Hemorrhage/Blood Loss/Bleeding1
Acquire models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Acquire M00555540Endoscopic ultrasound system, gastroenterology-urology1 death18 reports
- Acquire M00555580Endoscopic ultrasound system, gastroenterology-urology10 reports
- Acquire M00555560Endoscopic ultrasound system, gastroenterology-urology4 reports
Recent Acquire adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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