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ACHIEVE ADVANCE™ 2ACH25Recalls & reported problems

Medtronic, Inc. · CATHETER 2ACH25 25MM DIAMETER US · Class 2

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 00643169591004), received between Jan 27, 2020 and Feb 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Material Deformation1
  • Material Integrity Problem1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 19, 2021Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TWO OF THE ELECTRODE POLES ON THE MAPPING CATHETER DID NOT LOOK AS EXPECTED ON THE MAPPING SYSTEM AND THE MAPPING CATHETER APPEARED DEFORMED FROM ITS CIRCULAR SHAPE AND STRETCHED OUT. THE MAPPING CATHETER CABLE WAS RECONNECTED AND REPLACED WITHOUT RESOLVING THE ISSUE. THE MAPPING CATHETER WAS REMOVED FROM THE PATIENT. THE POLES LOOKED INTACT, BUT THE MAPPING CATHETER DID NOT HAVE A CIRCULAR SHAPE. THE MAPPING CATHETER WAS REPLACED, RESOLVING THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11348631 ↗
  • MalfunctionJan 27, 2020Detachment of Device or Device Component; Material Deformation; Material Twisted/Bent; Detachment of Device or Device Component; Material Deformation; Material Twisted/Bent

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER WAS REMOVED FROM THE SHEATH AS THE LUER OF THE BALLOON CATHETER BECAME LOOSE. ADDITIONALLY, THE MAPPING CATHETER WAS PHYSICALLY BENT. THE BALLOON CATHETER AND MAPPING CATHETER WERE REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9633646 ↗

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

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

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