Zero Tip M00513200Recalls & reported problems
Boston Scientific Corporation · Airway Retrieval Basket · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729414995), received between Nov 1, 2021 and Nov 30, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2023Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMONARY BASKET WAS USED IN THE BRONCHUS DURING THE REMOVAL OF INTRABRONCHIAL FOREIGN BODY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE BASKET WAS OPENED TO RETRIEVE THE FOREIGN BODY, THE CONNECTION PORT BETWEEN THE HANDLE AND THE WIRE FRACTURED. THE DEVICE WAS REMOVED, AND ANOTHER ZERO TIP PULMONARY BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240218 ↗MalfunctionNov 1, 2021Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMONARY BASKET WAS USED IN THE LUNGS DURING AN AIRWAY FOREIGN BODY RETRIEVAL PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, A BASKET WIRE BROKE WHEN ATTEMPTING TO CLOSE THE BASKET INSIDE THE PATIENT. THE BROKEN WIRE WAS STILL ATTACHED TO THE DEVICE. THE BASKET WAS PULLED OUT AND ANOTHER ZERO TIP PULMONARY BASKET 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 12728903 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.