Acquire™ Pulmonary M00552400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729986249), received between Nov 19, 2019 and Mar 2, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY OLYMPUS 25GA WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE NEEDLE SOMEHOW WAS FAULTY AND EVEN THOUGH THEY TESTED BEFORE HAND, DURING THE PROCEDURE THE NEEDLE WOULD NOT ADVANCE THROUGH THE SHEATH. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WHEN THE EVENT OCCURRED AND THERE WAS NO SCHEDULED DATE TO COMPETE THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO UNAVAILABILITY OF REPLACEMENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655939 ↗
• MalfunctionAug 10, 2021Leak/Splash; Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE BIOPSY (EBUS-TBNB) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN SALINE WAS BEING FLUSHED INTO THE NEEDLE, THE SALINE LEAKED FROM THE HANDLE. IN ADDITION, THE SHEATH ADJUSTMENT KNOB COULD NOT BE ADJUSTED OR LOCKED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND CANCELLED 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 12304543 ↗
• MalfunctionDec 5, 2020Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, STYLET KINKED INSIDE THE NEEDLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10951471 ↗
• InjuryNov 19, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE NEEDLE COILED TOO MUCH WHICH RESULTED IN THE NEEDLE POKING THE MEDIASTINUM AND CAUSING A PNEUMOTHORAX. IT IS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED. DESPITE THE REPORT OF PROLONGED HOSPITALIZATION, THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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: Pneumothorax

  MAUDE report 9340512 ↗