Recall archive
141 recalls · page 4 of 6
Reported Dec 30, 2020
IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Complaint trend regarding needle shaft gas leaks.
36 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2020
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional…
FDA (openFDA device enforcement)
Reported Nov 18, 2020
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient…
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may…
FDA (openFDA device enforcement)
Reported Nov 4, 2020
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter…
FDA (openFDA device enforcement)
Reported Sep 23, 2020
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
FDA (openFDA device enforcement)
Reported Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2020
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The needle surface deteriorated due to unexpected electrolysis during procedure.
9 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
FDA (openFDA device enforcement)
Reported May 6, 2020
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Imager II 5F Angiographic Catheters, 5 units per package.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Potential for tip detachment of Imager II 5F Angiographic Catheters
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming…
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 released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2019
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
FDA (openFDA device enforcement)
Reported Dec 18, 2019
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2019
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
FDA (openFDA device enforcement)
Reported May 29, 2019
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2019
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The sterile barrier may contain packaging seal defects.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2019
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Boston Scientific Corporation
Matched: Brand — Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2018
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
FDA (openFDA device enforcement)
Reported Oct 31, 2018
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
FDA (openFDA device enforcement)
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