Z-1671-2013Class III

RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510

Name: Z-1671-2013 RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510
Creator: Boston Scientific Corporation
Published: 2013-05-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-05-28 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use... on 2013-05-28. FDA classified it as Class III and gives the reason as "Product labeled with incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1671-2013
Classification: Class III
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-07-10
Terminated: 2014-02-10
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.
Product code: KNQ Dilator, Esophageal
Reason for recall: Product labeled with incorrect expiration date.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Lot/Batch Number: 091541

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

Product code KNQ

K050232Class IIRigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp / cleared 2005-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)