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ESTEEM 423657Recalls & reported problems

Convatec, Purchasing Department · N/A · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

  1. Feb 16, 2026Open, Classified

    Drainable large pouch may leak due to manufacturing issue.

    Z-1584-2026 · Root cause: Process control · FDA record ↗

  2. Feb 19, 2024Open, Classified

    Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.

    Z-1350-2024 · Root cause: Under Investigation by firm · FDA record ↗

Other Bag, drainage, with adhesive, ostomy devices

All Bag, drainage, with adhesive, ostomy devices →

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