Drugs & medicalClass II

Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…

Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation…

Read the official notice →
Date
2026-01-21
Country
United States
Brand
Boston Scientific
Product
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2)…
Classification
Class II
Units
US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-05-06
  2. US
    Drugs & medicalClass I

    Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL…

    Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding…

    FDA · DeviceBoston Scientific CorporationworldwideOfficial notice →
  3. 2026-03-18
  4. US
    Drugs & medicalClass II

    Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

    Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This…

    FDA · DeviceBoston Scientific CorporationUS Nationwide distribution.Official notice →
  5. 2026-02-11
  6. US
    Drugs & medicalClass I

    Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…

    FDA · DeviceBoston Scientific CorporationWorldwide distribution. US Nationwide including Puerto Rico; Algeria,…Official notice →
  7. 2025-10-22
  8. US
    Drugs & medicalClass II

    Boston Scientific Corporation recalls TENACIO Pump without InhibiZone; UPN: 72404420;

    The potential for devices to experience inflation and/or deflation performance issues or difficulties.

    FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice →
  9. US
    Drugs & medicalClass I

    Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker

    Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes…

    FDA · DeviceBoston Scientific CorporationWorldwideOfficial notice →
  10. 2025-10-01
  11. US
    Drugs & medicalClass II

    Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

    The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

    FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME,…Official notice →
All 68 Boston Scientific recalls →

Other drugs & medical recalls in the United States

  1. 2026-01-21
  2. US
    Drugs & medicalClass II

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

    Emphasizing instructions for LVP duration programming located in the IFU.

    FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI,…Official notice →
  3. US
    Drugs & medicalClass II

    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSI, System, Tomography, Computed, Emission

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this…

    FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France,…Official notice →
  4. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and…

    Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

    FDA · DeviceMedtronic NeuromodulationWorldwide - US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Mobius Imaging, LLC recalls Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

    AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

    FDA · DeviceMobius Imaging, LLCUS Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL,…Official notice →
  6. US
    Drugs & medicalClass II

    Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

    Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

    FDA · DeviceMedicrea InternationalUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Official notice →
  7. US
    Drugs & medicalClass II

    REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser…

    FDA · DeviceREPLIGEN CORPORATIONU.S.Official notice →
See all drugs & medical recalls →