The Recall Desk

FDA (Devices) recall action 70853

Laax, Inc. recalled 2 products on 2015-04-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-04-29
Critical
1
Units
8,308

Why these products were recalled

Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2015-04-29

    Laax TigerPaw System II Implantable Occlusion Fastener Recalled for Tissue Tearing

    Laax, Inc. is recalling the TigerPaw System II implantable occlusion fastener due to field reports of possible tissue tearing and bleeding during use.

    Product
    TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2015-04-29

    Laax Recalls TIGERPAW System II Implantable Occlusion Fasteners

    Laax, Inc. is recalling TIGERPAW System II implantable fasteners due to reports of tissue tearing and bleeding during use.

    Product
    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
    Category
    Distribution
    0 states