The FDA has posted 7 enforcement recalls from Abbott since 2025, including 5 Class I (most serious) recalls. Most recent report: Oct 22, 2025.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potent…
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potent…
Firm name as filed with the FDA: “Abbott”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.