H/S Elliptosphere™ Catheter • 5 French 61-4005Recalls & reported problems

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 (K013972); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 31, 2022Class IIOpen, Classified

   Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

   Z-0503-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013972. One submission often covers many models, so check the product and lot details in each record.

• Z-0504-2024 · Mar 31, 2022 · Open, Classified
  CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect u