Imager II M0064005030Recalls & reported problems
Boston Scientific Corporation · Urology Torque Catheter · Class 2
All models of IMAGER II (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729752004), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2018Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER RENAL DILATOR WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ONCE THE DEVICE WAS INSERTED, THE CATHETER PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMAGER RENAL DILATOR DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457522 ↗
Other CATHETER, UROLOGICAL devices
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- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
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- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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