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3M™ Attest™ 1243RERecalls & reported problems

3m Company · 3M™ Attest™ Chemical Integrator with Extender 1243RE, Type 5 · 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 30707387785759), received between May 5, 2023 and May 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMay 5, 2023Material Deformation

    STERILE PROCESSING REPORTED HAVING INTERMITTENT ISSUES WITH THE 3M ATTEST CHEMICAL INTEGRATORS (LOT # TD122025, REF# (B)(4)) NOT PASSING THEIR SETS, WITH TWO OF THE SAME LOT# IN A SET. ONE WILL PASS AND THE OTHER WILL NOT PASS. UPON INSPECTING THE INDICATORS, IT WAS NOTED THAT THE INK CARTRIDGE FROM THE ONE THAT DOESN'T PASS IS CONCAVED, WHILE THE ONE THAT DEPLOYED INK APPROPRIATELY DOESN'T LOOK CONCAVE. 3 SETS HAVE RECENTLY HAD THIS ISSUE. MANUFACTURER RESPONSE FOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS, 3M ATTEST (PER SITE REPORTER). THE HOSPITAL'S 3M REP WAS NOTIFIED. NO RESPONSE RECEIVED TO DATE.

    Patient problems: Insufficient Information

    MAUDE report 16875472 ↗

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