Medtronic, Inc. recalls CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Software problem has the potential for an inaccurate displayed longevity estimate.
Read the official notice →- Date
- 2026-11-04
- Country
- United States
- Brand
- Medtronic
- Product
- CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
- Classification
- Class II
- Units
- Worldwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic recalls
- 2026-11-04
Medtronic, Inc. recalls OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead…
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
FDA · DeviceMedtronic, Inc.US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA,…Official notice →- 2026-05-06
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac…
- 2026-01-21
Medtronic Inc recalls Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090…
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
FDA · DeviceMedtronic IncWorldwide - US Nationwide and the countries of Argentina, Australia, Austria,…Official notice →- 2025-12-10
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-07-30
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application,…
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's…
- 2025-07-23
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…
USOther drugs & medical recalls in the United States
- 2026-11-04
Stryker Leibinger GmbH & Co. KG recalls Precision Pointer Electromagnetic (8000-050-001)
Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.
FDA · DeviceStryker Leibinger GmbH & Co. KGWorldwide - US Nationwide distribution in the states of Alabama, Arizona,…Official notice →Boston Scientific Neuromodulation Corporation recalls Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu…
Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading…
FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR,…Official notice →Pentax of America Inc recalls PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
FDA · DevicePentax of America IncWorldwide - US Nationwide and International distribution - Pending.Official notice →BioMerieux SA recalls EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2
FDA · DeviceBioMerieux SAWorldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN,…Official notice →PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5 M12. Model Number: 722227.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →Canon Medical System, USA, INC. recalls ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL,…Official notice →