St. Jude Medical, Atrial Fibrillation Division, Inc. recalls TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal…
When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some…
Read the official notice →- Date
- 2024-01-31
- Country
- United States
- Brand
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Product
- TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2024-02-07
US- US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Failed Impurities/Degradation Specifications
- 2024-01-31
- US
Diasorin Inc. recalls DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased…
FDA · DeviceDiasorin Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - US
B-K Medical A/S recalls bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
FDA · DeviceB-K Medical A/SUS Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID,…Official notice → - US
Philips North America recalls Achieva 3.0T, Model No. 781177
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS,…Official notice → - US
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.