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Selectra Right-45 375535Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 2

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 04035479116798), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1
  • No Apparent Adverse Event1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 21, 2020Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

    WE RECEIVED NOTIFICATION FROM A HOSPITAL ON (B)(6) 2020 THAT AN EXPIRED CATHETER WAS USED DURING AN IMPLANT PROCEDURE. THE PROCEDURE OCCURRED ON (B)(6) 2020, BUT THE UBD OF THE CATHETER WAS (B)(6) 2019. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. NO PART OF THE CATHETER REMAINS IN THE PATIENT. THE CATHETER WAS DISCARDED BY THE HOSPITAL AFTER USE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9739140 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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