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U.S. Department of Health and Human Services

Class 3 Device Recall RigiflexTM 11 SingleUse Achalasia Balloon Dilator

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  Class 3 Device Recall RigiflexTM 11 SingleUse Achalasia Balloon Dilator see related information
Date Initiated by Firm May 28, 2013
Date Posted July 10, 2013
Recall Status1 Terminated 3 on February 10, 2014
Recall Number Z-1671-2013
Recall Event ID 65347
510(K)Number K050232  
Product Classification Dilator, esophageal - Product Code KNQ
Product RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510

Product Usage:
The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Code Information Lot/Batch Number: 091541
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
Manufacturer Reason
for Recall		 Product labeled with incorrect expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Boston Scientific sent an Urgent: Medical Device Recall letter to all affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The letter also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Follow-up communications will be made to the accounts that do not respond. For questions contact your local Sales Representative.
Quantity in Commerce 91
Distribution Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNQ and Original Applicant = BOSTON SCIENTIFIC CORP.
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