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Acquire™ Pulmonary M00552350Recalls & reported problems

Boston Scientific Corporation · Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
13
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729986225), received between Feb 24, 2020 and Feb 27, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component9
  • Adverse Event Without Identified Device or Use Problem3
  • Activation, Positioning or Separation Problem2
  • Difficult to Advance2
  • Device Contamination with Chemical or Other Material1
  • Difficult to Remove1
  • Leak/Splash1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • Foreign Body In Patient2
  • No Consequences Or Impact To Patient2
  • Hematoma1
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 27, 2026Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE INSIDE THE ENDOSCOPE. THE SCOPE WAS REMOVED AND THE BROKEN PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24469155 ↗
  • InjuryNov 21, 2023Detachment 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 PULMONARY NEEDLE WAS USED DUE TO A TUMOR IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE DETACHED INSIDE THE PATIENT. ATTEMPTS TO RETRIEVE THE DETACHED NEEDLE WERE UNSUCCESSFUL AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. FOLLOWING THE PROCEDURE, A CHEST X-RAY WAS PERFORMED, WHICH REVEALED A METAL MATERIAL APPROXIMATELY 10-MM LONG. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND NO INTERVENTION FOR THE DETACHED NEEDLE IS PLANNED AS THE PATIENT IS ILL, HAS A MALIGNANT TUMOR AND IS IN PALLIATIVE CARE.

    Patient problems: Foreign Body In Patient

    MAUDE report 18181464 ↗
  • InjuryAug 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE RIGHT LOWER PARATRACHEAL NODE DURING A TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE TIP BROKE AND REMAINED LODGED IN THE RIGHT LOWER PARATRACHEAL NODE. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH CONFIRMED THE NEEDLE TIP WAS LODGED IN THE NODE AND THEY WERE DISCHARGED THE SAME DAY. THE NEEDLE TIP COULD NOT BE RETRIEVED WITHOUT MEDIASTINOSCOPY OR VIDEO-ASSISTED THORACOSCOPIC (VAT) SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND THE PATIENT'S OUTCOME IS CURRENTLY UNKNOWN.

    Patient problems: Foreign Body In Patient

    MAUDE report 17512031 ↗
  • InjuryMay 8, 2023Detachment 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 PULMONARY NEEDLE WAS USED IN THE BRONCHIAL WALL DURING A LUNG BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE TIP BROKE AND REMAINED STUCK IN THE BRONCHIAL WALL DURING THE THIRD PUNCTURE. THE NEEDLE TIP WAS REMOVED USING FORCEPS AND THE PATIENT HAD MILD BLEEDING. THE BLEEDING WAS TREATED BY ADMINISTERING A 500MG TRANSAMINE TABLET TO THE PATIENT TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER ACQUIRE PULMONARY NEEDLE. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN OF THE THORAX WAS SUGGESTED TO ENSURE NO FOREIGN BODY REMAINED, HOWEVER IT IS UNKNOWN AT THIS TIME IF ONE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 16886818 ↗
  • InjuryApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE MEDIASTINAL LYMPH NODES DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, ABOUT 1 CM OF THE NEEDLE DISTAL TIP DETACHED. THE PROCEDURE WAS IMMEDIATELY STOPPED AND A SEARCH FOR THE TIP OF THE NEEDLE IN THE PATIENT AIRWAY, ENDOTRACHEAL TUBE, AND THE EXTERNAL AREA AROUND THE PATIENT WAS UNSUCCESSFUL. THE PATIENT WAS MOVED TO A FLUOROSCOPY BED, AND THEY SEARCHED THE PATIENT'S LUNGS RADIOLOGICALLY USING FLUOROSCOPY AND 3D FLUOROSCOPY BUT COULD NOT LOCATE THE MISSING NEEDLE TIP. DURING CLEANING, THE TECH BRUSHED THE MISSING NEEDLE TIP OUT OF THE PROXIMAL END OF THE SCOPE. THE PROCEDURE WAS COMPLETED USING A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16795821 ↗
  • InjuryFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNG DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ACQUIRE NEEDLE FRACTURED AND LODGED ITSELF IN THE MUCOSA OF THE TRACHEA. IT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16368457 ↗
  • MalfunctionOct 13, 2022Leak/Splash; Material Too Rigid or Stiff; Activation, Positioning or Separation Problem; Material Integrity Problem; Leak/Splash; Material Too Rigid or Stiff; Activation, Positioning or Separation Problem; Material Integrity Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE WAS INSERTED INTO THE BRONCHIAL TREE AND THE SHEATH WAS BLOCKED AND RIGID. IT HAD BEEN SLIGHTLY FORCED BUT IT LEAKED, AND IT WAS NO LONGER POSSIBLE TO ADJUST. AFTER THE PROCEDURE, IT WAS NOTED THE DISTAL PART OF THE BRONCHOSCOPE WAS DAMAGED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY DUE TO THE INABILITY TO ADJUST THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 15601297 ↗
  • MalfunctionJun 13, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FIRST EXIT OF THE SHEATH FROM THE TIP OF THE DEVICE WAS SLIGHTLY DIFFICULT BUT THE NEEDLE REACHED THE LUMP TO BE PUNCTURED. THE OPERATOR RE-INTRODUCED THE DEVICE INTO THE ENDOSCOPE CHANNEL, BUT THE SHEATH DID NOT SLIDE FORWARD. THE NEEDLE HANDPIECE WAS BLOCKED AND DID NOT ALLOW ANY MOVEMENT OF EITHER THE SHEATH OR THE NEEDLE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AS A SECOND NEEDLE DEVICE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 14679622 ↗
  • InjuryDec 3, 2021Adverse 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 PULMONARY NEEDLE WAS USED DURING A BIOPSY PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT POST PROCEDURE, WHILE HOSPITALIZED, THE PATIENT HAD A SIGNIFICANT MEDIASTINAL HEMATOMA. THE MEDIASTINAL HEMATOMA WAS OBSERVED 4 DAYS AFTER THE BIOPSY PROCEDURE. REPORTEDLY, ANTICOAGULANTS WERE USED AS A TREATMENT FOR THE HEMATOMA. THE PHYSICIAN IS UNSURE IF THERE WAS ANY RELATIONSHIP BETWEEN THE NEEDLE DEVICE AND THE HEMATOMA.

    Patient problems: Hematoma

    MAUDE report 12924621 ↗
  • InjurySep 2, 2021Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED ON A 4R LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE 4R LYMPH NODE WAS COMPLICATED TO REACH. THE FIRST PASS WITH THE ACQUIRE NEEDLE WAS SUCCESSFUL. THEN THE PHYSICIAN SWITCHED TO AN OLYMPUS 20GA NEEDLE SINCE HE THOUGHT IT WOULD BE EASIER FOR HIM, HOWEVER, HE STILL HAD DIFFICULTIES. THEY WENT BACK TO USING THE ACQUIRE NEEDLE WHICH WAS ALREADY BENT ON THE DISTAL PART OF THE NEEDLE. WHEN HE WANTED TO INSERT THE NEEDLE ON THE SHEATH, THE NEEDLE BROKE IN THE TRACHEA. THE BROKEN PIECE OF THE NEEDLE WAS RETRIEVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE OLYMPUS 20GA NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12417619 ↗
  • MalfunctionApr 15, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS)PROCEDURE PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, WHILE OUTSIDE OF THE PATIENT, THE STYLET WAS NOT ABLE TO ADVANCE THROUGH THE SHAFT OF THE NEEDLE. THE DEVICE WAS SUCTIONED OUT MULTIPLE TIMES, HOWEVER THE STYLET WAS NOT ABLE TO BE ADVANCED WITHIN IN THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THERE WAS A FOREIGN MATERIAL BLOCKING THE INSIDE OF THE NEEDLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11673224 ↗
  • MalfunctionMar 6, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY OLYMPUS NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS STUCK WHEN THEY PULLED OUT THE SCOPE AND THE NEEDLE WAS STICKING OUT. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT ONE PORTION OF THE NEEDLE WAS RETURNED BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9802070 ↗
  • InjuryFeb 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE RIGHT UPPER LOBE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE TIP OF THE NEEDLE BROKE AND DETACHED IN THE PATIENT'S AIRWAY. THE NEEDLE WAS RETRIEVED USING A PAIR OF GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9744435 ↗

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Sources and updates

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