Polaris X™ M0047005D0Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729270188), received between Sep 15, 2022 and Sep 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Perforation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Perforation2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2022Material Perforation; Defective Device; Material Perforation; Defective Device
DURING PREPARATION FOR A PROCEDURE AS TWO POLARIS X CATHETERS WERE TAKEN OUT OF THE BOX, THERE WERE SCRATCHES ON THE CATHETER SHAFTS WHERE THE BLUE PLASTIC WAS PULLING AWAY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETERS HAVE BEEN RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15429571 ↗MalfunctionSep 15, 2022Material Perforation; Material Perforation
DURING PREPARATION FOR A PROCEDURE AS TWO POLARIS X CATHETERS WERE TAKEN OUT OF THE BOX, THERE WERE SCRATCHES ON THE CATHETER SHAFTS WHERE THE BLUE PLASTIC WAS PULLING AWAY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETERS HAVE BEEN RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15429557 ↗
Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices
- Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16St. Jude Medical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths358 reports
- IntellaMap Orion™ M004RC64S0Boston Scientific Corporation · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths356 reports
- ACHIEVE™ 990063-020Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 deaths129 reports
- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 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.
How reports and recalls are matched · Editorial policy · Report an error on this page