FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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.
- Recall number
- Z-1671-2013
- Recalling firm
- Boston Scientific Corporation
- 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.
- Status
- Terminated
- Initiated
- 2013-05-28
- Posted
- 2013-07-10
- Terminated
- 2014-02-10
- Reason
- Product labeled with incorrect expiration date.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Lot/Batch Number: 091541
- 510(k) numbers
- ["K050232"]
- PMA numbers
- not on file
- Product code
- KNQ
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28