CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Amplatzer Amulet Left Atrial Appendage Occluder recalled by Abbott
Abbott is recalling Amplatzer Amulet Left Atrial Appendage Occluder, distributed nationwide in the US. The recall was initiated on 10 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0191-2027
- FDA event ID
- 99844
- Recalling firm
- Abbott, Plymouth, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2026
- FDA classified
- 16 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 10 Sep 2026 | Recall initiated by company | |
| 16 Oct 2026 | Classified by FDA | +36 days |
| 28 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Product as listed by the FDA
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
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Which lots are affected?
UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott
All 21Other Masks, Gloves & PPE recalls
All 451| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |