Abbott recalls
14 recalls in our records from 2018 to 2026: 14 FDA medical devices.
Recalls with full detail pages
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Abbott medical device recall: TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Earlier and other recalls
These link to the official agency notice.
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Abbott medical device recall: Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1.… Official notice ↗
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
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Abbott medical device recall: Amplatzer TorqVue LP Delivery System Official notice ↗
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…
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Abbott medical device recall: Abbott NT2000iX Radiofrequency Official notice ↗
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for…
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Abbott medical device recall: Abbott Amplatzer Steerable Delivery Sheath Official notice ↗
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
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Abbott medical device recall: Abbott TactiCath Sensor Enabled Official notice ↗
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid…
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Abbott medical device recall: FIRMap" Catheter Official notice ↗
Incorrect product labeling.
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Abbott medical device recall: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter Official notice ↗
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
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Abbott medical device recall: Amplatzer Steerable Delivery Sheath Official notice ↗
Instructions for use were updated.
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Abbott medical device recall: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Official notice ↗
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices…
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Abbott medical device recall: TactiCath Quartz Contact Force Ablation Catheter Official notice ↗
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
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Abbott medical device recall: Merlin PCS 3650 Software Upgrade Kit Official notice ↗
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously…
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Abbott medical device recall: St. Jude Medical Confirm Rx Insertable Cardiac Monitor Official notice ↗
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
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Abbott medical device recall: Thoratec HeartMate 3 LVAS Implant Kit Official notice ↗
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.