Polaris X™ M0047004D0Recalls & reported problems
Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729270171), received between Apr 28, 2022 and Apr 28, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE WITH A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THERE WAS GREASE COMING OUT OF THE CATHETER HANDLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14242243 ↗MalfunctionApr 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION FOR AN ABLATION PROCEDURE WITH A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THERE WAS GREASE IN THE CATHETER HANDLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14242163 ↗MalfunctionApr 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE WITH A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THERE WAS GREASE COMING OUT OF THE CATHETER HANDLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14242158 ↗
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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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