Graspit M0063204010Recalls & reported problems
Boston Scientific Corporation · Nitinol Stone Retrieval Forceps · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729341758), received between Mar 23, 2020 and Mar 2, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component2
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GRASPIT NITINOL STONE RETRIEVAL FORCEPS WAS USED IN THE URETER DURING A FLEXIBLE URETERORENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, THE FORCEPS OF THE GRASPIT BROKE OFF INSIDE THE FLEXIBLE URETEROSCOPE. ADDITIONALLY, THE SHEATH AT THE DISTAL END SNAPPED OFF. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11398697 ↗InjuryMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GRASPIT NITINOL STONE RETRIEVAL FORCEPS WAS USED IN THE URETER DURING A LITHOTRIPSY PROCEDURE FOR REMOVAL OF RENAL STONES PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN TRYING TO REMOVE A LASERED STONE DURING THE PROCEDURE THE FORCEPS BROKE AT THE TIP WERE THE FORCEPS OPEN. THE FRACTURED FORCEPS WAS REMOVED FROM THE PATIENT WITH ANOTHER GRASPING FORCEPS. HOWEVER, THE URETER WAS PUNCTURED FROM MULTIPLE ATTEMPTS TO REMOVE THE BROKEN FORCEPS. AN ATTEMPT TO INSERT A NEPHROSTOMY FAILED, AND BILATERAL RETROPERITONEAL DRAINS WERE INSERTED INSTEAD. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON APRIL 1, 2020. THE PATIENT WAS REPORTED TO BE A CHILD, AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE OKAY.
Patient problems: Perforation
MAUDE report 9865234 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.