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FOGARTY 410405FPRecalls & reported problems

Edwards Lifesciences LLC · FOGARTY BILIARY BALLOON PROBE 5F 40CM · Class 2 · Implant

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K193379); they may or may not involve this specific model.

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. Oct 6, 2022Open, Classified

    Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

    Z-0147-2023 · Root cause: Packaging · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193379. One submission often covers many models, so check the product and lot details in each record.

  • Z-0146-2023 · Oct 6, 2022 · Open, Classified
    Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Mod

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