Recall archive
138 recalls · page 5 of 6
Reported Mar 28, 2018
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Stent possibly unable to be fully released from the delivery system.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2018
ACCOLADE SR Pacemaker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific…
23 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2017
RESONATE EL ICD VR, Model D432, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The devices have an incorrect firmware configuration.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2017
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
FDA (openFDA device enforcement)
Reported Aug 23, 2017
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The device can deliver an atypical amount of energy due to memory corruption inside the device.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2017
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2017
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease…
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 voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve…
FDA (openFDA device enforcement)
Reported Mar 15, 2017
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired…
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an…
FDA (openFDA device enforcement)
Reported Jan 11, 2017
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
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 conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This…
FDA (openFDA device enforcement)
Reported May 4, 2016
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
FDA (openFDA device enforcement)
Reported Apr 27, 2016
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is…
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 recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks;…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2…
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 voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found…
FDA (openFDA device enforcement)
Reported Jan 20, 2016
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 13, 2016
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Potential for separation of the proximal handle from the shaft.
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number…
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 voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer…
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 is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2015
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2015
AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the…
FDA (openFDA device enforcement)
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