Recall archive
138 recalls · page 2 of 6
Reported Nov 20, 2024
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their…
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an…
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 has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
30 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This…
FDA (openFDA device enforcement)
Reported May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of…
47 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F.…
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly,…
FDA (openFDA device enforcement)
Reported Nov 29, 2023
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Poor image quality due to fluid ingress in the lens.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced…
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy…
FDA (openFDA device enforcement)
Reported Mar 15, 2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an…
FDA (openFDA device enforcement)
Reported Nov 16, 2022
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 9, 2022
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product details · Reason for recall — There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Product may be mislabeled.
1 more product in this recall
FDA (openFDA device enforcement)
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