Recall archive
141 recalls · page 1 of 6
Reported Oct 21, 2026Updated Oct 26, 2026
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with…
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include…
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result,…
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs).…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential for breach in sterile barrier of device packaging.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Rapid Refill Continuous Injection System, UPN M00566001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from…
FDA (openFDA device enforcement)
Reported Jul 8, 2026
CRE Pro Wireguided 6-8mm 240cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential sterile breach of the pouches in which devices are packaged.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated…
FDA (openFDA device enforcement)
Reported May 13, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand · Product · Product details — Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2026
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result…
FDA (openFDA device enforcement)
Reported Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon…
FDA (openFDA device enforcement)
Reported Oct 22, 2025
ACCOLADE SR SL (Model L300)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
33 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and…
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2025
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings…
3 more products in this recall
FDA (openFDA device enforcement)
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