LANDANGER
LANDANGER · Model B40246 · UDI-DI 03661219006589
10
510(k) clearances
845
Adverse events (11 deaths)
20
Recalls
308
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging. |
| 2023-07-24 | Cook Vandergrift, Inc. | Sterility of device may be compromised due to breach of the chevron seal of the packaging |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi |
| 2022-02-09 | Maquet Cardiovascular, LLC | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses. |
| 2020-02-06 | Deroyal Industries, Inc. Lafollette | The sterile packaging has the potential to be compromised. |
| 2020-01-13 | TELEFLEX MEDICAL INC | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
| 2020-01-13 | TELEFLEX MEDICAL INC | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.