Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Recall notice
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
We’re still writing up this recall
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/1932733-abbott-recalls-amplatzer-amulet-left-atrial-appendage-occluder-model-numbers · Recall date September 10, 2026 · FDA enforcement record: FDA #Z-0191-2027
Cite this page
“Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2.” GovInfoNow, recall dated September 10, 2026. https://govinfonow.com/recall/1932733-abbott-recalls-amplatzer-amulet-left-atrial-appendage-occluder-model-numbers. Based on FDA recall #Z-0191-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0191-2027%22&limit=1).
How to tell if you have this one
- Brand
Abbott- Category
Medical device
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0191-2027 (September 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0191-2027 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.