Expect Pulmonary M00558220Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 08714729861409), received between Nov 23, 2016 and Sep 16, 2026 — classified as 18 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (19 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an Endobronchial Ultrasound-guided Transbronchial Needle Aspiration procedure performed on (b)(6)2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786544 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an EBUS (endobronchial ultrasound) bronchoscopy-TBNA procedure performed on (b)(6)2026.During the procedure, the needle could not be deployed smoothly, and the needle tip pierced through the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786354 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784814 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an EBUS-TBNA procedure performed on (b)(6)2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784798 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an EBUS (endobronchial ultrasound) bronchoscopy-TBNA procedure performed on (b)(6) 2026.During the procedure, the needle could not be deployed smoothly, and the needle tip pierced through the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784796 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary needle was used during an endobronchial ultrasound (EBUS) -TBNA procedure performed on (b)(6) 2026.During the procedure, the needle failed to deploy smoothly, and the needle tip was noted to be protruding from the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784764 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an endobronchial ultrasound (EBUS) -TBNA procedure performed on (b)(6)2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification has been requested from the customer regarding the procedural outcome. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784761 ↗
• MalfunctionSep 15, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure performed on (b)(6) 2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772978 ↗
• MalfunctionSep 15, 2026Mechanical Problem; Material Puncture/Hole

  It was reported to Boston Scientific Corporation that an Expect Pulmonary was used during an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS) -TBNA procedure performed on (b)(6) 2026.During the procedure, the needle could not be extended smoothly, and the needle tip punctured the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772775 ↗
• MalfunctionJul 17, 2026Break; Difficult to Flush; Mechanical Problem; Material Puncture/Hole; Suction Problem

  It was reported to Boston Scientific Corporation that an Expect Pulmonary Olympus 22ga was used during an endobronchial ultrasound (EBUS) procedure performed on (b)(6) 2026.During the procedure, the needle cracked at the top causing it not to hold suction or flush out material. The needle was not able to advance since it got caught in the tip of the sheath causing the sheath to be punctured. The procedure was completed with another Expect Pulmonary Olympus 22ga.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864043 ↗
• MalfunctionApr 24, 2026Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE DID NOT COME OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF INNER SHAFT OR SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977846 ↗
• MalfunctionApr 23, 2026Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA NEEDLE WAS USED FOR AN ULTRASONOGRAPHY OF AIRWAY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FRONT END OF THE PUNCTURE NEEDLE SHEATH WAS MILD BENT, CAUSING THE NEEDLE TIP TO PENETRATE THE SHEATH. ANOTHER EXPECT PULMONARY OLYMPUS 22GA NEEDLE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 24973702 ↗
• MalfunctionApr 11, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY WAS INTENDED TO BE USED IN AN ENDOBRONCHIAL ULTRASOUND (EBUS) BRONCHOSCOPY TO TREAT A LUNG MASS ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WOULD NOT COME OUT OF THE END OF THE SCOPE. THE PROCEDURE WAS CANCELLED; THE PHYSICIAN WAS NOT ABLE TO COLLECT THE NEEDED SPECIMEN. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851867 ↗
• InjuryJan 6, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A PIECE OF THE SHAFT OF THE NEEDLE BROKE AND DETACHED INTO THE PATIENT'S AIRWAY. THE DEVICE WAS REMOVED, AND THE DETACHED FRAGMENT WAS RETRIEVED WITH A BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982153 ↗
• MalfunctionDec 19, 2025Mechanical Problem; Material Puncture/Hole; Material Twisted/Bent; Mechanical Problem; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE BRONCHUS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS VERY DIFFICULT AND REQUIRED CONSIDERABLE FORCE TO ADVANCE THE NEEDLE. THE EXPECT WAS REMOVED FROM THE ENDOSCOPE. IT WAS TESTED AGAIN OUTSIDE OF THE PATIENT, AND THE NEEDLE PIERCED THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849730 ↗
• InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE EXPECT PULMONARY WAS USED IN THE LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE PUNCTURING THE LYMPH NODE. PHYSICIAN WAS ABLE TO SUCTION OUT THE PIECE OF THE NEEDLE THAT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607903 ↗
• MalfunctionOct 31, 2025Mechanical Problem; Material Puncture/Hole; Use of Device Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Use of Device Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN RECTUM DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS TBNA) PROCEDURE ON (B)(6)2025. DURING THE PROCEDURE, THE SHEATH FROM THE NEEDLE PUSHES BACK INTO THE WORKING CHANNEL ALTHOUGH THE SHEATH WAS LOCKED WITH THE KNOB AND PUNCTURE WAS NOT POSSIBLE. THE SHEATH ADVANCEMENT CHANGES SIGNIFICANTLY EVEN WITH PROPER FIXATION WHEN ANGULATING THE EBUS DEVICE AND MUST BE READJUSTED AFTER EACH REMOVAL AND REINSERTION OF THE NEEDLE, WHICH IS VERY TIME-CONSUMING. A NON BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE SHEATH WAS PUNCTURED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442243 ↗
• MalfunctionSep 24, 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 EXPECT PULMONARY NEEDLE WAS USED IN THE BRONCHI DURING A STENT DEPLOYMENT PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED 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 23132617 ↗
• MalfunctionJul 7, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE SEVEN GROUPS OF LYMPH NODES DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE OUT OF THE SHEATH HAD GREAT RESISTANCE, NEEDLE APPEARANCE DEFORMATION. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE NEEDLE PUNCTURED THE SHEATH. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420117 ↗
• MalfunctionJun 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING AN ULTRASOUND BRONCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE TIP HAD PIERCED THE NEEDLE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284608 ↗
• MalfunctionJun 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING AN ULTRASOUND BRONCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, PUNCTURE NEEDLE COULD NOT CROSS THE TRACK OF THE SHEATH AND CAME OUT FROM THE SIDE OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. 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 22209332 ↗
• MalfunctionMay 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY WAS USED IN THE LUNGS DURING AN ULTRASOUND-GUIDED BRONCHIAL NEEDLE ASPIRATION BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE NEEDLE TIP HAS PUNCTURED THE SHEATH. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 22052082 ↗
• MalfunctionMar 24, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE UPPER LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE SHEATH AND WAS NOT POSSIBLE TO PUSH IT THROUGH. AFTER REMOVING THE SCOPE FROM THE PATIENT, THE HEALTH CARE PROFESSIONAL TRIED TO PUSH THE NEEDLE THROUGH. HOWEVER, THE NEEDLE TIP SHOOT OUT THROUGH THE SIDE OF THE SHEATH. ANOTHER EXPECT PULMONARY 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 21675573 ↗
• MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, ABOUT 3CM OF THE DISTAL TIP OF THE NEEDLE BROKE OFF INTO THE SPECIMEN CUP WHEN THEY EXTRACTED THE SPECIMEN. ANOTHER DEVICE 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 21616604 ↗
• InjuryNov 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING AN ULTRASOUND BRONCHOSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE PUNCTURED THROUGH THE SIDE OF THE SHEATH AND INJURED THE PHYSICIAN. WHEN THE NEEDLE WAS INSERTED, THE PHYSICIAN GOT INJURED/PUNCTURED. THE PHYSICIAN WENT TO AN INFECTIOUS DISEASE HOSPITAL TO RECEIVE A HEPATITIS B ANTIBODY INJECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686084 ↗