Skip to content

Orbiter™ ST M0043200070Recalls & reported problems

Boston Scientific Corporation · Bidirectional Steerable Diagnostic Catheter · Class 2

Data updated Oct 18, 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 08714729877820), received between Jan 24, 2018 and Jan 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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

Device problems

  • Bent1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 24, 2018Bent; Bent

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT THE DEVICE HAD BENT PINS IN THE CONNECTOR. DURING PREPARATION FOR AN ABLATION PROCEDURE WITH AN ORBITER ST BIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER, THE DEVICE WOULD NOT CONNECT TO THE CABLE. THE DEVICE HAD BENT PINS. NO PATIENT COMPLICATIONS OCCURRED AS THE DEVICE DID NOT ENTER THE PATIENT. DEVICE ANALYSIS REVEALED THREE GAPS IN THE ADHESIVE BETWEEN THE TIP AND THE CATHETER SHAFT INSULATION.

    Patient problems: No Patient Involvement

    MAUDE report 7216383 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page