Abbott
Complete recall history across all FDA and CPSC categories — 19 total recalls
Abbott appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (19)
FDA medical device enforcement actions by Abbott
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... | Abbott has become aware of a limited number of tip detachment events during c... | Class I |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... | Abbott has become aware of a limited number of tip detachment events during c... | Class I |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... | Abbott has become aware of a limited number of tip detachment events during c... | Class I |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ... | Abbott has become aware of a limited number of tip detachment events during c... | Class I |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ... | Abbott has become aware of a limited number of tip detachment events during c... | Class I |
| Mar 17, 2025 | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 | Device may have a small breach in the proximal end of the shaft under the str... | Class II |
| Mar 17, 2025 | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-... | Device may have a small breach in the proximal end of the shaft under the str... | Class II |
| Sep 28, 2023 | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning gen... | Certain NT2000iX RF generators were serviced using a tool that was subsequent... | Class II |
| Jun 12, 2023 | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a per... | There is an overall reported incidence rate of 0.77% related to observed or p... | Class I |
| Jun 9, 2022 | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ... | When connected to the EnSite Precision Navigation System, an affected TactiCa... | Class II |
| Apr 28, 2022 | FIRMap" Catheter, 60mm Basket | Incorrect product labeling. | Class II |
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM... | Class II |
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM... | Class II |
| Nov 16, 2021 | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Intro... | Class II |
| Nov 9, 2021 | Amplatzer Steerable Delivery Sheath | Instructions for use were updated. | Class II |
| May 22, 2020 | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 ... | High rate of reported complaints for the loss of contact force information wh... | Class II |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if n... | Class II |
| Nov 19, 2018 | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ... | The device is unable to pair with the mobile app due to the device incorrectl... | Class II |
| Apr 5, 2018 | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... | Reports of outflow graft twist occlusions. Patients whose devices experience... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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