Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Read the official notice →- Date
- 2026-07-29
- Country
- United States
- Brand
- Boston Scientific
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Classification
- Class II
- Units
- International distribution in the countries of Italy, Austria, France,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Boston Scientific recalls
- 2026-08-12
USBoston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN:…
Potential for breach in sterile barrier of device packaging.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice →- 2026-07-29
- US
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice → - US
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
- US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA · DeviceBoston Scientific CorporationInternational distribution in the states of Austria, Spain, France, Germany,…Official notice → - 2026-07-22
- US
Boston Scientific Corporation recalls Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution. OUS consignee list pending.Official notice → - 2026-07-08
- US
Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2026-07-29
- US
ICU Medical Inc. recalls Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's…
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- US
Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
FDA · DeviceParagon 28, Inc.US nationwide, Australia, Canada, The Netherlands, and New ZealandOfficial notice → - US
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
- US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA · DeviceBoston Scientific CorporationInternational distribution in the states of Austria, Spain, France, Germany,…Official notice → - US
Medline Industries, LP recalls MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their…
- US
Wilcox Industries Corp. recalls The intended use is to be paired with a weapon for aiming purposes.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.