Medtronic Neuromodulation recalls Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI…
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Read the official notice →- Date
- 2022-06-01
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, AR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Neuromodulation recalls
- 2022-08-31
USMedtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…
Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US distribution including in the states of AK, AL,…Official notice →- US
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…
Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2022-06-01
- US
Medtronic Neuromodulation recalls Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice → - 2022-05-04
- US
Medtronic Neuromodulation recalls MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1)…
There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY,…Official notice → - 2022-01-05
- US
Medtronic Neuromodulation recalls Model B35200 - Percept PC BrainSense Implantable Neurostimulator
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice → - 2021-12-01
- US
Medtronic Neuromodulation recalls Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor…
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
FDA · DeviceMedtronic NeuromodulationUS Nationwide, including PR. There was government distribution but no military…Official notice →
Other drugs & medical recalls in the United States
- 2022-06-01
- US
TELEFLEX MEDICAL INC recalls (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck…
Reports received of torn corrugated breathing tubes.
FDA · DeviceTELEFLEX MEDICAL INCWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Microbiologics Inc recalls KWIK-STIK" plus: Clostridium perfringens
Labeling error.
FDA · DeviceMicrobiologics IncDistributed US Nationwide to IA, TN and internationally to Mexico, Colombia,…Official notice → - US
Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as…
FDA · DeviceDevicor Medical Products IncUS Nationwide distribution in the states of DE, KY, NY, OH, WV.Official notice → - US
Olympus Corporation of the Americas recalls Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
- US
Accriva Diagnostics, Inc. recalls The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12…
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays…
FDA · DeviceAccriva Diagnostics, Inc.US Nationwide distribution in the state of California.Official notice → - US
International Science & Technology, LP, DBA Diamatrix Ltd. recalls Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm…
Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".
FDA · DeviceInternational Science & Technology, LP, DBA Diamatrix Ltd.Worldwide distribution - US Nationwide distribution in the states of MN, TX…Official notice →