Zero Tip M00513210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729415008), received between May 11, 2021 and Dec 12, 2024 — classified as 1 injury, 5 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Break; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP WAS USED IN THE BASAL SEGMENT OF THE LEFT LOWER LUNG DURING A FIBROBRONCHOSCOPIC ALVEOLAR LAVAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS KNOT ABOUT 4CM AWAY FROM THE TIP OF THE BASKET. THE BASKET WAS GENTLY REMOVED, AND IT WAS OBSERVED BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910745 ↗
• MalfunctionNov 29, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMONARY BASKET WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC BILE DUCT STONE CRUSHING DURING PROCEDURE PERFORMED ON OCTOBER 23, 2023. DURING UNPACKING, THE HANDLE WAS BROKEN. 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 18232446 ↗
• InjuryJan 27, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  NOTE: THE ZERO TIP AIRWAY RETRIEVAL BASKET IS INTENDED TO BE USED TO ENDOSCOPICALLY REMOVE FOREIGN BODIES IN THE AIRWAY. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMO BASKET WAS USED IN THE COMMON BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A ZERO TIP PULMO BASKET WAS USED IN THE COMMON BILE DUCT; HOWEVER, THE BASKET WIRE KINKED AFTER PLACEMENT AND GOT STUCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16254127 ↗
• MalfunctionJan 5, 2023Physical Resistance/Sticking

  BASKET WIRE KINKED AFTER PLACEMENT INTO COMMON BILE DUCT, GETTING STUCK.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16101849 ↗
• MalfunctionMay 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMONARY BASKET WAS TO BE USED IN THE TRACHEA FOR A REMOVAL OF TRACHEAL FOREIGN BODY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, WHEN THE PACKAGE WAS UNPACKED, THE SHEATH OF THE ZERO TIP DEVICE WAS FOUND TO BE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP PULMONARY BASKET. 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 11837959 ↗
• MalfunctionMay 11, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP PULMONARY BASKET WAS TO BE USED IN THE LUNGS FOR A FOREIGN BODY REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE SHEATH DETACHED OUTSIDE THE PATIENT AND COULD NOT BE ADVANCED INTO THE SCOPE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. 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 11806752 ↗