NA M0062401000Recalls & reported problems
Boston Scientific Corporation · Ureteral Dilatation System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 08714729005322), received between Sep 4, 2019 and Feb 9, 2021 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Defective Device1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGID URETERAL DILATORS AND SHEATHS WAS USED FOR A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE CAME WITH A FINGER OF A GLOVE INSIDE OF THE PACKAGING WAS NOTICED AS CONFIRMED BY A PHOTO OF THE COMPLAINT DEVICE SUBMITTED BY THE CUSTOMER. NO PATIENT COMPLICATIONS WERE 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: Insufficient Information
MAUDE report 11300948 ↗InjurySep 4, 2019Defective Device; Defective Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGID URETERAL DILATOR AND SHEATH WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DILATE AROUND A SEMI-LARGE STONE. HOWEVER, UPON WITHDRAWING THE DILATOR, IT BROKE IN HALF. REPORTEDLY, HE WENT BACK AND RETRIEVED THE DEVICE WITH A GRASPER. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8960287 ↗
Other DILATOR, CATHETER, URETERAL devices
- Porges Coloplast RBD014Coloplast A/S · DILATOR, CATHETER, URETERAL1 recall0 reports
- Bard® X-Force® Balloon Dilation Catheter 998706C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL38 reports
- Bard® X-Force® Balloon Dilation Catheter 998606C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL27 reports
- Bard® X-Force® Balloon Dilation Catheter 998006C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL25 reports
- Bard® X-Force® Balloon Dilation Catheter 998806C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL23 reports
- Bard® X-Force® Balloon Dilation Catheter 998504C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL16 reports
- Passport M0062181100Boston Scientific Corporation · DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998004C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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