FDA Class II Recall: Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve,… by Abbott Medical

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Abbott Medical. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Abbott Medical should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Abbott Medical directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Abbott Medical’s FDA history

Argus HQ has recorded 39 total FDA actions tied to Abbott Medical: 0 warning letters, 39 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Abbott Medical's recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was Abbot Navitor, Vision Technology, Transcatheter Aortic Heart recalled?

FDA's recall record states the reason as: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

Who should I contact about this recall?

Contact Abbott Medical directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Abbott Medical had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 39 total FDA actions tied to Abbott Medical, including 39 recalls and 0 warning letters.

Related enforcement actions

• Recall: Abbott Medical — Class II recall: Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 →
• Recall: Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 →
• Recall: Abbott Medical — Class II recall: Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0… →
• Recall: Abbott Medical — Class II recall: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 365… →
• Recall: Abbott Medical — Class III recall: Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@… →
• Recall: Abbott Medical — Class III recall: Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is inte… →
• Recall: Abbott Medical — Class II recall: Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 m… →
• Recall: Abbott Medical — Class II recall: Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO… →