Abbott Medical recalls
12 official recalls and safety alerts involving Abbott Medical since 2023-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott Medical or the relevant agency.
- 2026-06-17
USAbbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →- 2025-11-19
- US
Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
- 2025-04-23
- US
Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The…
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and…Official notice → - 2025-01-01
- US
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the…
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2024-12-04
- US
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted…
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA,…Official notice → - 2024-11-27
- US
Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
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…
FDA · DeviceAbbott MedicalNew York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman,…Official notice → - 2024-07-31
- US
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-07-24
- US
Abbott Medical recalls Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of ALABAMA,…Official notice → - 2024-07-10
- US
Abbott Medical recalls Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of…
FDA · DeviceAbbott MedicalUS: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA,…Official notice → - 2024-05-08
- US
Abbott Medical recalls Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2023-09-27
- US
Abbott Medical recalls Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF…
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of…
FDA · DeviceAbbott MedicalU.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech…Official notice → - 2023-09-20
- US
Abbott Medical recalls Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device…
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →