Zero TipRecalls & reported problems across all models
Boston Scientific Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 326
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls
- 0
We found 8 models of Zero Tip by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 326 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 14, 2026 — classified as 119 injuries, 207 malfunctions.
The most frequently reported specific device problem is “Break” (145 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 Zero Tip problems
Device problems
- Break145
- Detachment of Device or Device Component93
- Adverse Event Without Identified Device or Use Problem69
- Difficult to Open or Close32
- Material Split, Cut or Torn22
- Material Deformation12
- Nonstandard Device10
- Tear, Rip or Hole in Device Packaging9
Patient problems
- No Clinical Signs, Symptoms or Conditions177
- No Consequences Or Impact To Patient77
- No Known Impact Or Consequence To Patient20
- Urinary Tract Infection19
- Foreign Body In Patient13
- Sepsis7
- No Patient Involvement6
- Device Embedded In Tissue or Plaque4
Zero Tip models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zero Tip M0063901050DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- Zero Tip M0063901010DISLODGER, STONE, BASKET, URETERAL, METAL15 reports
- Zero Tip M0063901020DISLODGER, STONE, BASKET, URETERAL, METAL6 reports
- Zero Tip M00513210BRONCHOSCOPE ACCESSORY6 reports
- Zero Tip M0063901030DISLODGER, STONE, BASKET, URETERAL, METAL5 reports
- Zero Tip M0063901040DISLODGER, STONE, BASKET, URETERAL, METAL4 reports
- Zero Tip M00513200BRONCHOSCOPE ACCESSORY2 reports
- Zero Tip M0063901000DISLODGER, STONE, BASKET, URETERAL, METAL1 report
Recent Zero Tip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Detachment of Device or Device Component
It was reported that a Zero Tip Basket device was used during a Ureteroscopy Laser Lithography procedure. During the procedure, the end of the basket cage fell off. Reportedly, they grabbed another basket to retrieve the cage from the previous basket. The procedure was completed with another of the same device with no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754793 ↗InjuryJul 8, 2026Break
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE, REPORTEDLY, WHEN THE BASKET WAS USED TO RETRIEVE THE STONE FRAGMENT, THE TIP BROKE INSIDE THE PATIENT. THE PHYSICIAN WAS USING THE BASKET WITH A LASER AND THERE WERE NO PIECES OF FRAGMENT WAS LEFT INSIDE THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25755185 ↗MalfunctionJul 8, 2026Detachment of Device or Device Component
It was reported that during Ureterolithotomy procedure, a Zero Tip basket was used, and it was found that the whole basket fell off outside of the patient. The procedure was completed with another of the same device. No patient complications were report
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751066 ↗InjuryJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE BASKET BROKE INSIDE THE PATIENT WHILE PULLING OUT A KIDNEY STONE. THE BROKEN TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428727 ↗MalfunctionMay 15, 2026Break; Nonstandard Device; Material Split, Cut or Torn
IT WAS REPORTED THAT ZERO TIP BASKET DEVICE WAS USED DURING A TRANSURETHRAL RENOLITHOTRIPSY PROCEDURE. DURING PROCEDURE, THE WIRE GOT DAMAGE IN THE BASKET SECTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THE SHEATH WAS FOUND TO BE MELTED AT THE DISTAL END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191484 ↗MalfunctionApr 14, 2026Nonstandard Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE A ZERO TIP WAS USED. IT WAS FOUND THAT THE WIRE WAS DAMAGED AND WAS SEPARATED AND DETACHED FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872666 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE A ZERO TIP NITINOL STONE RETRIEVAL WAS USED. THE BASKET BROKE OFF INSIDE THE URETER DURING ATTEMPT TO REMOVE THE BROKEN NEPHROSTOMY TUBE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 24866763 ↗MalfunctionApr 2, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT TWO ZERO TIP BASKET DEVICES WERE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET PORTION BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND ZERO TIP BASKET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO ZERO TIP BASKET DEVICES USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767737 ↗MalfunctionApr 1, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT TWO ZERO TIP BASKET DEVICES WERE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET PORTION BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND ZERO TIP BASKET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO ZERO TIP BASKET DEVICES USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753973 ↗MalfunctionMar 11, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A ZERO TIP WAS USED DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE. PRIOR TO PROCEDURE, A BLACK SPECS WERE FOUND FLOATING IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568785 ↗InjuryMar 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A ZERO TIP WAS USED DURING PROCEDURE. IT WAS FOUND THAT THE BASKET BROKE INSIDE THE PATIENT RESULTING IN ADDITIONAL SURGERY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562941 ↗InjuryMar 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, TONE RETRIEVAL BASKET WAS ADVANCED THROUGH A SEMIRIGID URETEROSCOPE AND DEPLOYED TO CAPTURE THE STONE; HOWEVER, A RESISTANCE WAS ENCOUNTERED DURING ATTEMPTED WITHDRAWAL OF THE BASKET WITH THE CAPTURED STONE, AND THE BASKET BROKE IN THIS ATTEMPT. REPORTEDLY, THE URETEROSCOPE WAS WITHDRAWN AND A 16 FR FOLEY CATHETER WAS PLACED FOR URINARY DRAINAGE, AND A GUIDEWIRE WAS LEFT IN PLACE VIA THE CATHETER. A CLEAR URINE DRAINAGE WAS OBSERVED AT THE CONCLUSION OF THE CASE WITH NO PATIENT COMPLICATIONS.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24562929 ↗MalfunctionMar 10, 2026Nonstandard Device; Detachment of Device or Device Component
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROLITHOTOMY (TUL) PROCEDURE. POST PROCEDURE, THE FRONT FOUR CLAWS AND THE ENTIRE BASKET DETACHED. REPORTEDLY, THE DETACHED BASKET DID FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562905 ↗MalfunctionMar 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A ZERO TIP BASKET WAS USED DURING A URETEROLITHOTOMY PROCEDURE. DURING THE PROCEDURE CLOSURE, IT WAS FOUND THAT THE WHOLE BASKET FELL OFF BUT IT DID NOT FALL INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501036 ↗MalfunctionMar 2, 2026Material Separation
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE OUTER SHEATH FROM THE BASKET DURING THE CASE AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490076 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page