Gore Cardioform Septal Occuder
- Recalling firm
- W. L. Gore & Associates (NZ) Limited
- Product
- Gore CARDIOFORM Septal Occuder. [Device]. Affected: Catalogue Number - GSXE0020B, GSXE0025B, GSXE0030B
- Reason
- The manufacturer has identified that some GORE CARDIOFORM Septal Occluder delivery systems may be missing the guidewire port. This issue may result in an inability to prepare or introduce the device, potentially leading to increased procedure time. For devices that have already been implanted, no adverse events or complications related to this issue are anticipated.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-15
- Status
- Ongoing
- Distribution
- New Zealand - Healthcare Professional
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cd8d0ab5-0d1e-4796-9c31-323b89aefe9d