FDA MedWatch Alerts
Printable Version   Email to a friend

Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

August 14, 2008
Audience: Cardiologists, hospital risk managers
[Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.

[August 14, 2008 - Recall Notice - FDA]

Latest FDA MedWatch Alerts...

FDA MedWatch Alerts Archive

2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2002: Feb | Mar | Apr | May | Jun | Jul | Sep | Oct | Nov

More News Resources


MedNotes
Latest Drug Information Updates

Promacta
Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

Banzel
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Apriso
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

LoSeasonique
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Acanya
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

Toviaz
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Vimpat
Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

Astepro
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

Rapaflo
Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

Cinryze
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Akten
Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

AdreView
AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

Sancuso
Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

Nplate
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Xenazine
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

More...