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4WEB Medical ASTS-SA-LG1612-SPRecalls & reported problems

4web Medical · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812998045075), received between Aug 2, 2023 and Aug 2, 2023 — classified as 1 injury.

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

  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryAug 2, 2023No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED TO THE MANUFACTURER THAT UPON OPENING THE FIRST OUTER BLISTER SEAL AND PROCEEDING TO OPEN THE INNER BLISTER OF A STERILE PACKAGED IMPLANT, IT WAS NOTICED THAT A PART OF THE EXTERNAL PULL TAB WAS LOOSE FROM THE SEAL. ANOTHER STERILE IMPLANT WAS OPENED TO CONTINUE WITH THE SURGERY. THERE WAS NO IMPACT TO THE SURGERY AND THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17445947 ↗

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Sources and updates

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