# Class II recall Z-0191-2027: Abbott

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0191-2027 |
| Recalling firm | Abbott |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 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 |
| Reason | Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). |
| Distribution | Worldwide - US Nationwide distribution. |
| Recall initiated | 2026-09-10 |
| Reported | 2026-10-28 |
| Firm location | Plymouth, MN, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0191-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.