Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the…
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Read the official notice →- Date
- 2022-06-01
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of CA, ND,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Perfusion Systems recalls
- 2024-05-22
US
- 2024-03-27
US
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
FDA · DeviceMedtronic Perfusion SystemsUS and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy,…Official notice →- 2023-02-08
US
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or…
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…Official notice →- 2022-01-19
US
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R…
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →- 2021-12-01
US
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
There is potential for intermittent electrical connectivity between the console and probe.
FDA · DeviceMedtronic Perfusion SystemsDistribution in US - IL, KS, and UT Distribution outside of US to Australia…Official notice →- 2021-10-13
US
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion…
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the state of…Official notice →
Other drugs & medical recalls in the United States
- 2022-06-01
US
ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
FDA · DeviceConvaTec, IncDistributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL,…Official notice →US
Smith & Nephew Orthopaedics GmbH recalls INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Right nails were anodized, marked, and labelled as left nails and vice versa
FDA · DeviceSmith & Nephew Orthopaedics GmbHDistributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and…Official notice →US
Stradis Healthcare recalls Surgical Suture Kit
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
US
Invacare Corporation recalls Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The…
FDA · DeviceInvacare CorporationWorldwide distribution - US Nationwide distribution in the states of AK, AR,…Official notice →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 →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 →