Boston Scientific 5450 RIGIFLEX II Single Use Achalasia Balloon Dilator 30mm (x) Back; Dental. CRE PRO Wireguided Esophageal/Pyloric/Biliary Balloon Dilatation Catheters provide consistent performance for balloon endoscopy for optimal control, efficiency and performance. She had to drink large vol. The CRE Pulmonary Balloon Dilatation Catheter is intended to be used to endoscopically dilate strictures of the airway tree. ANSM has been informed of the implementation of a recall made by Boston Scientific. Boston Scientific 5450 Rigiflex II Achalasia Balloon Dilator 30-10/14-90 Item Past Expiration +1(833)330-3033. Applicant. Device Name. OEM: Boston Scientific. Size: 30mm x 10cm x 90cm. Biliary Stricture And Stone. Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. About this database Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. : 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label . 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. Question - Answer 0. The balloon demonstrated here is a Boston Rigiflex II balloon, which has radiological markers defining the middle and both ends of the balloon. The second is a failure of the lower esophageal sphincter (LES) to relax. Rigiflex II Single-Use Achalasia Balloon Dilators Rigiflex II Single-Use Achalasia Balloon Dilators* Order Number GTIN Balloon Inflated O.D. Call 08048718991 36% Response Rate. : 5451 lot/batch no. Standard sizes are: 8-9-10mm. A 56 year old lady presented with an 18 month history of dysphagia (especially for solids), regurgitation and 3 stone weight loss. Price: $49.99. This item is out of stock. From 1989 to 2001, 66 patients underwent endoscopic balloon dilation for achalasia; three perforations (4.5 %) occurred, with no mortalities. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; Hospital Beds,Stretchers & Furniture; . Specifications HPIS Code 710_240_30_0 Latex Free No UNSPSC 42294909 SIMM00554510. Achalasia literally means "failure to relax." Adding to cart The item has been added Device Rigiflex II Single Use Achalasia Balloon Dilator Model / Serial Product Description medical_device Manufacturer Boston Scientific Manufacturer Her dysphagic symptoms had recurred over 3 months. In Stock! K050232. Pneumatic dilation (PD) remains an important treatment for achalasia ( Fig. 10-11-12mm. Go to: Footnotes In stock. 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 ). . 1 EA. Multi-Diameter Balloon Dilators is designed to deliver 3 distinct, pressure-controlled diameters in 1 balloon at 3 separate pressures. Recommended use with Achalasia Pneumatic Hand Pump and Monitor Order #5320 Model #: 5450. Boston Scientific has . . No Pre-loaded Guidewire in the Balloon Dilatation Catheter. 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). . Email Me When In Stock. 15 . RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR. CODE: NS10000565. Amalgamators; Burs & Bur Blocks; Curing-Light; Dental Chairs & Stools; Dental Imaging & X-Ray; Dental Supplies; Handpieces; Instruments; Other Dental Equipment; Scalers; Emergency & EMT. 22. AED - Defibrillators; 1 EA. : m00554510 catalogue no. Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 . Achalasia is a rare swallowing disorder characterized by two problems with the esophagus. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Am J Gastroenterol 93: 1064-1067 [Google Scholar] : 5451 lot/batch no. Categories. Boston Scientific 5450 Rigiflex II Achalasia Balloon Dilator 30-10/14-90 (x) 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. 1 ). 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. Boston Scientific 5451 RigiflexII Achalasia Balloon Dilator 35-10/14-90 (x) Back; Dental. of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold," Boston Scientific said in a statement to ICIJ. The CRE PRO Catheters are indicated for use in the removal of difficult biliary stones (Dilatation Assisted Stone Extraction, DASE). Expiration Date: 2021. Thirty seven patients underwent pneumatic dilatation with 30 mm Rigiflex balloon (Boston Scientific, USA) for a duration of 1 minute. Even the single session of dilatation is successful in maintaining long-lasting dysphagia-free interval. In addition, these drugs are associated with side effects such as peripheral edema, headache, and hypotension that occur in up to 30% of patients [5]. We also offer a . These balloons are intended for dilation of the lower esophageal sphincter (LES) and relief from symptoms in patients who suffer with achalasia. Categories. Code Information: Lot/Batch Number: 091541: Recalling Firm/ Manufacturer: Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234: Manufacturer Reason for Recall BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Boston Scientific NephroMax Balloon Catheter - Independent Reviews by Clinicians for Clinicians. Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90Item Past Expiration +1(833)330-3033. Amalgamators; Burs & Bur Blocks; Curing-Light; Dental Chairs & Stools; Dental Imaging & X-Ray; Dental Supplies; Handpieces; Instruments; Other Dental Equipment; Scalers; Emergency & EMT. One Boston Scientific Place Natick, MA 01760-1537 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center W06G609 Silver spring MD 20993-0002 Re: 050232 Trade/Device Name: RigiflexTM Il Single-Use Achalasia Balloon Dilator Regulation Number: 21 CFR 876.5980 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. The users concerned received the attached mail (12/06/2013) (21 KB). "We have coordinated several recalls across many countries in a timely manner," the . Description. Packaging. Description. Response was assessed by Eckardts score at 3 and 6. Recall of RIGIFLEX II ACHALASIA BALLOON DILATOR According to Health Canada (via FOI), this recall . Make Offer. FAQ; About the database . Boston Scientific is initiating a medical device recall of the RIGIFLEXTM II Single Use Achalasia Balloon Dilator. OEM: Boston Scientific Expiration Date: 2019-2021 Size: 40mm x 10cm x 90cm . Shafgat F., Castell D. (1998) Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distension time. Item Past Expiration. BOSTON SCIENTIFIC 5450 RIGIFLEX II SINGLE USE ACHALASIA BALLOON DILATOR 4.6MM X 30MM X 10CM Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90. RIGIFLEX II Single Use Achalasia Balloon Dilator - 35mm x 10cm x 90cm Boston Scientific. UPC: Current Stock: 5. 035747. Dilation Product Ordering Information MAXFORCE AND RIGIFLEX BALLOON DILATORS ALSO AVAILABLE MAXFORCE TTS SINGLE-USE ESOPHAGEAL BALLOON DILATORS Order Number Inflated O.D. the treatment of esophageal achalasia. 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. UPC: Current Stock: This item is out of stock. Please email info@medicalmaterials.com or call us at 561-375-7857 and we will try to locate the product with our . Stock Allocated QTY : / Remaining QTY : / Allocation Reset Date : SIMM00554520. $5,499.99. 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. Contact Us (Microvasive) achalasia balloon dilator (diameter 35 mm) or a Witzel endoscopic pneumatic dilator. Critical Care : m00554510 catalogue no. Stone Management; Biliary Stents; Pancreatic Stents; Biopsy Currently, the Rigiflex pneumatic dilator (Boston Scientific, Boston, MA, USA) is the most commonly used balloon for achalasia therapy . Description. Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. : 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label . Stock Allocated QTY : / Remaining QTY : / Allocation Reset Date : SIMM00554520. The first is a lack of peristalsis, which is the involuntary process of propelling food from your mouth to your stomach. 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. The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. 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. PD causes circumferential stretching of the lower esophageal sphincter (LES) with subsequent controlled tearing of its muscle fibers. $650.00. Simplified Scope CompatabilityFor CRE PRO Wireguided Balloon Dilatation Catheter compatible with 2.8 mm+ working channel endoscopes and 3.7 mm+ working channel duodenoscopes. Packaging. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . $30.00) Model #: 5451 OEM: Boston Scientific Expiration Date: 2021 Size: 35mm x 10cm x 90cm . 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. PD has similar effectiveness compared with surgery (Heller's myotomy) and is a very cost-effective treatment option. SIMM00554510. Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. 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 . Medical Device Safety Alert: Boston Scientific RIGIFLEX II Single Use Achalasia Balloon Dilator Manufacturer Boston Scientific. Reference Part Numbers are not the same in all countries/regions. The previously placed radio-opaque markers can be used in combination with the radio-opaque markers in the balloon itself to ensure accurate positioning. Dysphagic symptoms significantly improved 12 weeks . 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. The device is indicated for adult use only. Balloon Length (cm) Inflation Pressures Working Length (cm) Catheter Size Recommended Guidewire** (mm) (Fr) (psi) (kPa) (mm) (Fr) (in) Packaging M00554500 08714729719106 30 90 10 20 138 90 4.6 14 .038 Each 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 510 (k) Number. NATICK, MA 01760 -1537. 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. Please contact our technical team for additional support. Smaller sizes (6-8, 8-10, 10-12, 12-15mm) are also compatible with 3.2 mm working channel duodenoscopes. Achalasia Balloon Dilators Balloon Length (CM) 10.0 Recommended Guidewire (IN) 0.038 Balloon Inflated OD (MM) 30 35 40 Working Length (CM) 90 Package Quantity 1 Request Pricing Product Documentation Instructions for Use Instructions for use are found inside the product packaging. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. Boston Scientific M00554520 Rigiflex II Single Use Achalasia Balloon Dilator 40-10 / 14-90Item Past Expiration 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. 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. As the first balloon indicated for the airway-it is designed with three-in-one technology and provides successive, gradual dilation of strictures. Used to dilate the lower esophageal sphincter in patients with achalasia. The dura-tion of action is short, the symptom improvement is very limited, and their efficacy decreases over time. $1,299.99. Add to Cart. 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. 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. 12-13.5-15mm. RIGIFLEX II Achalasia Balloon Dilators $749.00. Both the Society of American Gastrointestinal Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG.