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…
Read the official notice →- Date
- 2023-09-27
- Country
- United States
- Brand
- Abbott Medical
- Product
- Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF…
- Classification
- Class II
- Units
- U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Abbott Medical recalls
- 2024-11-27
USAbbott 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
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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
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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 → - 2023-09-20
- 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 →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
R A Medical Services recalls MINISCAV (tm) Vacuum Pump
Inadequate documentation of acceptance activity
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Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which…
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ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50,…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
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GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX…
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
FDA · DeviceGE Medical Systems Information Technologies IncDistribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA,…Official notice → - US
Tytek Medical Inc recalls TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from…
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
FDA · DeviceTytek Medical IncOH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China…Official notice → - US
Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet…