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.
Read the official notice →- Date
- 2024-07-31
- Country
- United States
- Brand
- Abbott Medical
- Product
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 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 →- 2024-07-24
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 →
Other drugs & medical recalls in the United States
- 2024-07-31
US
LINK BIO CORP recalls LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser…
FDA · DeviceLINK BIO CORPUS Nationwide distribution in the states of FL, GA, KS, OH, WI.Official notice →US
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a…
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ,…Official notice →US
B Braun Medical Inc recalls Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U…
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with…
FDA · DeviceB Braun Medical IncDomestic distribution nationwide. International distribution to Canada.Official notice →US
Beckman Coulter Inc. recalls Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →US
Medtronic Neuromodulation recalls A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605,…
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice →US
Radiometer Medical ApS recalls ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for…
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting…
FDA · DeviceRadiometer Medical ApSWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →