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Boston Scientific has . : 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label . Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90. We conclude from our study that, though the era of POEM has already arrived, pneumatic balloon dilatation is still the most commonly performed endoscopic procedure for achalasia, especially in resource-poor developing countries. Question - Answer 0. BOSTON SCIENTIFIC 5450 RIGIFLEX II SINGLE USE ACHALASIA BALLOON DILATOR 4.6MM X 30MM X 10CM : m00554510 catalogue no. Description. OEM: Boston Scientific. Description. Applicant. Packaging. Device Name. To obviate these technical and procedural impediments, we have devised a new technique for the introduction of the Microvasive Rigiflex Achalasia Balloon Dilator (ABD) (Boston Scientific Corp, Boston, Mass), which is done under direct endoscopic visualization, without a guidewire and fluoroscopic assistance. Response was assessed by Eckardts score at 3 and 6. We also offer a . Categories. "We have coordinated several recalls across many countries in a timely manner," the . Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Multi-Diameter Balloon Dilators is designed to deliver 3 distinct, pressure-controlled diameters in 1 balloon at 3 separate pressures. Call 08048718991 36% Response Rate. About this database Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Since 3 sizes can be achieved with 1 balloon pass, the procedure is potentially shorter and less expensive than dilation with a single-diameter balloon. Recommended use with Achalasia Pneumatic Hand Pump and Monitor Order #5320 Achalasia Balloon Dilators; Catalog Number Inflated Diameter Balloon Length Sheath Diameter Working Length Qty ; 3302 : 30mm 90fr : 10cm : 5.3mm : 100cm : 3304 : 35mm 105fr : 10cm : 5.3mm : 100cm . UPC: Current Stock: 5. Price: $49.99. (Microvasive) achalasia balloon dilator (diameter 35 mm) or a Witzel endoscopic pneumatic dilator. Even the single session of dilatation is successful in maintaining long-lasting dysphagia-free interval. Both the Society of American Gastrointestinal $650.00. Reference Part Numbers are not the same in all countries/regions. Expiration Date: 2021. No Pre-loaded Guidewire in the Balloon Dilatation Catheter. The dura-tion of action is short, the symptom improvement is very limited, and their efficacy decreases over time. K050232. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Model #: 5450. AED - Defibrillators; Achalasia is a rare swallowing disorder characterized by two problems with the esophagus. Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. Contact Us Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. This product line is serviced by the following clinical division (s): Endoscopy Surgery The products on this website are available for sale in the United States. $30.00) Model #: 5451 OEM: Boston Scientific Expiration Date: 2021 Size: 35mm x 10cm x 90cm . Item Past Expiration. RIGIFLEX II Single Use Achalasia Balloon Dilator - 35mm x 10cm x 90cm Boston Scientific. Boston Scientific has become aware that the pouch label expiration date on a single lot/batch of RIGIFLEXTM II Single Use Achalasia Balloon Dilators is labeled with the incorrect expiration date, 0213-12. Medical device safety alert: boston scientific rigiflex ii single use achalasia balloon dilator medical device manufacturer, boston scientific, has issued a field safety notice concerning rigiflex ii single use achalasia balloon dilator with: material no. Biliary Stricture And Stone. Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 . Thirty seven patients underwent pneumatic dilatation with 30 mm Rigiflex balloon (Boston Scientific, USA) for a duration of 1 minute. The users concerned received the attached mail (12/06/2013) (21 KB). Dilation Product Ordering Information MAXFORCE AND RIGIFLEX BALLOON DILATORS ALSO AVAILABLE MAXFORCE TTS SINGLE-USE ESOPHAGEAL BALLOON DILATORS Order Number Inflated O.D. : 5451 lot/batch no. Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90Item Past Expiration +1(833)330-3033. Currently, the Rigiflex pneumatic dilator (Boston Scientific, Boston, MA, USA) is the most commonly used balloon for achalasia therapy . ANSM has been informed of the implementation of a recall made by Boston Scientific. Make Offer. FAQ; About the database . : 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label . 22. Boston Scientific NephroMax Balloon Catheter - Independent Reviews by Clinicians for Clinicians. Add to Cart. Medical device safety alert: boston scientific rigiflex ii single use achalasia balloon dilator medical device manufacturer, boston scientific, has issued a field safety notice concerning rigiflex ii single use achalasia balloon dilator with: material no. SIMM00554510. NATICK, MA 01760 -1537. 510 (k) Number. A 56 year old lady presented with an 18 month history of dysphagia (especially for solids), regurgitation and 3 stone weight loss. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; Hospital Beds,Stretchers & Furniture; . : 5451 lot/batch no. RIGIFLEX II Achalasia Balloon Dilators She had to drink large vol. Standard sizes are: 8-9-10mm. Boston Scientific 5451 RigiflexII Achalasia Balloon Dilator 35-10/14-90 (x) Back; Dental. Smaller sizes (6-8, 8-10, 10-12, 12-15mm) are also compatible with 3.2 mm working channel duodenoscopes. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Size: 30mm x 10cm x 90cm. Categories. Stock Allocated QTY : / Remaining QTY : / Allocation Reset Date : SIMM00554520. Email Me When In Stock. The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. Her dysphagic symptoms had recurred over 3 months. The Centers for Medicare and Medicaid Services (CMS) and Capital Bridge, LLC, who is the National Correct Coding Initiative (NCCI) contractor, has informed the American Speech-Language-Hearing Association (ASHA) that they will change the modifier indicator for when CPT codes 92611 (Motion fluoroscopic evaluation of swallowing function by cine or video recording) and 74230 (Radiologic. SIMM00554510. . Specifications HPIS Code 710_240_30_0 Latex Free No UNSPSC 42294909 Please email info@medicalmaterials.com or call us at 561-375-7857 and we will try to locate the product with our . Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. $1,299.99. As the first balloon indicated for the airway-it is designed with three-in-one technology and provides successive, gradual dilation of strictures. From 1989 to 2001, 66 patients underwent endoscopic balloon dilation for achalasia; three perforations (4.5 %) occurred, with no mortalities. The balloon demonstrated here is a Boston Rigiflex II balloon, which has radiological markers defining the middle and both ends of the balloon. A Rigiflex Balloon (Boston Scientific, MA) is then inserted ( Figure 1) over the guidewire and passed under fluoroscopic guidance until centred over the gastro-esophageal junction ( Figure 2 ). Balloon Dilatation of Achalasia of Cardia 6,335 views Jul 5, 2015 38 Dislike Share Save monzahmed 8.18K subscribers This video shows the balloon dilatation of the lower oesophageal sphincter. These balloons are intended for dilation of the lower esophageal sphincter (LES) and relief from symptoms in patients who suffer with achalasia. It was reported to boston scientific corporation that a rigiflex balloon was used during an esophagogastroduodenoscopy (egd) procedure in the gastroesophageal junction performed on (b) (6). the treatment of esophageal achalasia. Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. Boston Scientific 5450 Rigiflex II Achalasia Balloon Dilator 30-10/14-90 Item Past Expiration +1(833)330-3033. Packaging. This item is out of stock. . Stone Management; Biliary Stents; Pancreatic Stents; Biopsy Please contact our technical team for additional support. Am J Gastroenterol 93: 1064-1067 [Google Scholar] . Used to dilate the lower esophageal sphincter in patients with achalasia. Boston Scientific 5450 Rigiflex II Achalasia Balloon Dilator 30-10/14-90 (x) Code Information: Lot/Batch Number: 091541: Recalling Firm/ Manufacturer: Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234: Manufacturer Reason for Recall 1 EA. Achalasia is a disorder of the esophagus characterized by increased lower esophageal sphincter (LES) tone, lack of LES relaxation with swallowing and aperistalsis of the body of the esophagus. Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90Item Past Expiration 00:38: This is a case of a 60-year-old female who has achalasia and previously responded to pneumatic balloon dilatation of the esophagus. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. In stock. Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . CRE Single-Use Pulmonary Balloon Dilatation Catheter The CRE Pulmonary Balloon Dilatation Catheter is intended to be used to endoscopically dilate strictures of the airway tree. Boston Scientific is initiating a medical device recall of the RIGIFLEXTM II Single Use Achalasia Balloon Dilator. $749.00. 10-11-12mm. Go to: Footnotes PD causes circumferential stretching of the lower esophageal sphincter (LES) with subsequent controlled tearing of its muscle fibers. The CRE PRO Catheters are indicated for use in the removal of difficult biliary stones (Dilatation Assisted Stone Extraction, DASE). Adding to cart The item has been added Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . Amalgamators; Burs & Bur Blocks; Curing-Light; Dental Chairs & Stools; Dental Imaging & X-Ray; Dental Supplies; Handpieces; Instruments; Other Dental Equipment; Scalers; Emergency & EMT. BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. 55 For pricing information contact your Boston Scientific Sales Representative or Customer Service at 1.888.272.1001 Section Table of ContentsPrev Page Next Page Main Table of Contents Dilation CRE PRO Balloon Dilatation Catheters Description. Pneumatic dilation (PD) remains an important treatment for achalasia ( Fig. Achalasia literally means "failure to relax." Critical Care Stock Allocated QTY : / Remaining QTY : / Allocation Reset Date : SIMM00554520. : m00554510 catalogue no. Recall of RIGIFLEX II ACHALASIA BALLOON DILATOR According to Health Canada (via FOI), this recall . 9 November 2011 - Boston Scientific Corporation (NYSE:BSX) has received CE Mark for the use of its Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy. 1 EA. RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR. CRE PRO Wireguided Esophageal/Pyloric/Biliary Balloon Dilatation Catheters provide consistent performance for balloon endoscopy for optimal control, efficiency and performance. DOTmed.com is a medical and hospital equipment classified advertising site for new and used medical equipment for sale or wanted, we also list refurbished medical equipment. The CRE Pulmonary Balloon Dilatation Catheter is intended to be used to endoscopically dilate strictures of the airway tree. The device is indicated for adult use only. The first is a lack of peristalsis, which is the involuntary process of propelling food from your mouth to your stomach. Quantity: Decrease Quantity of RIGIFLEX II Single Use Achalasia Balloon Dilator - 40mm x 10cm x 90cm Increase Quantity of RIGIFLEX II Single Use Achalasia Balloon Dilator - 40mm x 10cm x 90cm. The second is a failure of the lower esophageal sphincter (LES) to relax. Boston Scientific 5450 RIGIFLEX II Single Use Achalasia Balloon Dilator 30mm (x) Back; Dental. Simplified Scope CompatabilityFor CRE PRO Wireguided Balloon Dilatation Catheter compatible with 2.8 mm+ working channel endoscopes and 3.7 mm+ working channel duodenoscopes.