Bard® Platinum Class™ II Flat Wire Stone Basket 045390Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741066900), received between Apr 21, 2017 and Dec 12, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TIP OF THE DORMIA STONE BASKET WAS KINKED ONCE THE DOCTOR OPENED THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981724 ↗
• MalfunctionJan 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PHARMACY COMPLAINED ABOUT A DEFECTIVE BARD FLATWIRE STONE BASKETS. HOWEVER, THE DEFECT WAS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11171706 ↗
• MalfunctionDec 5, 2019Use of Device Problem; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED THAT THE BASKET WOULD NOT CLOSE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9417539 ↗
• MalfunctionDec 4, 2019Failure to Capture; Failure to Capture; Defective Device

  IT WAS REPORTED THAT THE PRODUCT DID NOT PERFORM AS INTENDED, AND DID NOT RESULT IN SUCCESSFUL STONE RETRIEVAL EVERY TIME THEY USED IT. THE RESPONDENT STATED THEY HAD TO USE DIFFERENT BASKETS A FEW TIMES TO RETRIEVE STONES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413354 ↗
• InjuryApr 21, 2017Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BASKET ALLEGEDLY "POKED A TINY HOLE IN THE PATIENTS URETER, 2 OR 3 TIMES". HOWEVER, THE PATIENT'S OUTCOME WAS NOT COMPROMISED. THE PHYSICIAN PLACED A STENT IN THE PATIENT, AS PER NORMAL PROCEDURE FOLLOWING BASKETING OF STONE PIECES.

  Patient problems: Laceration(s)

  MAUDE report 6511356 ↗