The Recall Desk

Manufacturer

Laax, Inc.

2 recalls in our database name Laax, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
1
Severe
1
Most recent
2015-04-29

Of the 2 recalls from Laax, Inc. we have scored against our rubric, 1 (50%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • CriticalFDA (Devices)·Z-1462-2015·2015-04-29

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1461-2015·2015-04-29

    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
    Medical Device
    Distribution
    Distributed nationwide