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Cable, SureLink™ M004560001P0Recalls & reported problems

Boston Scientific Corporation · Cable for Diagnostic Catheter · Class 2

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 08714729879664), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Packaging Compromised” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Packaging Compromised1

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.

  • MalfunctionMay 17, 2018Device Packaging Compromised; Device Packaging Compromised

    IT WAS REPORTED THAT THE BLUE SEAL ON THE PACKAGE WAS OPEN (PEELED OFF). THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7521858 ↗

Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices

All CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.