OVERLOOKED

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Class IIOngoing

Abbott recalls Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Abbott
Reason
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99844…

Products

  1. Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034

    Codes/lots: UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.Recall no. Z-0191-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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