Class II recall Z-0191-2027: Abbott
Class II recall Z-0191-2027: Abbott (Minnesota): Abbott. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 13 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (12 MN records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0191-2027: Abbott and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.
What is the FDAPulse record for Class II recall Z-0191-2027: Abbott in Minnesota?
Class II device recall Z-0191-2027 by Abbott: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
How does Class II recall Z-0191-2027: Abbott compare to other Minnesota FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
Class II recall Z-0191-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0191-2027 | MN | 2026-10-28 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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