Expect PulmonaryRecalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 3 models of Expect Pulmonary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 29, 2026 — classified as 22 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Bent” (30 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 Expect Pulmonary problems
Device problems
- Bent30
- Material Puncture/Hole21
- Mechanical Problem18
- Detachment of Device or Device Component17
- Adverse Event Without Identified Device or Use Problem13
- Device Contamination with Chemical or Other Material12
- Difficult to Advance6
- Material Integrity Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient42
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient1
- Needle Stick/Puncture1
- Pulmonary Embolism1
Expect Pulmonary models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Expect Pulmonary M00558220BRONCHOSCOPE (FLEXIBLE OR RIGID)60 reports
- Expect Pulmonary M00558250BRONCHOSCOPE (FLEXIBLE OR RIGID)36 reports
- Expect Pulmonary M00559250Biopsy needle1 report
Recent Expect Pulmonary adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Puncture/Hole; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936396 ↗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, 2026Obstruction of Flow; Device Contamination with Chemical or Other Material; Material Integrity Problem; Physical Resistance/Sticking
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA WAS USED FOR MEDIASTINAL LYMPH NODE IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LUER LOCK WAS CRACKED, AFTER ABOUT 7 PASSES OF THE NEEDLE, MAKING IT IMPOSSIBLE TO FLUSH THE NEEDLE WITH WATER OR AIR TO EXPEL THE SPECIMEN. ADDITIONALLY, LITTLE BLACK PIECES OF FOREIGN MATERIAL WERE FOUND IN THE SPECIMEN JAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852033 ↗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 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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