RigiflexTM 11 Single-Use Achalasia Balloon Dilator — Class III medical device recall Z-1671-2013
Terminated recall by Boston Scientific Corporation, reported 2013-07-17, distributed nationwide. Product labeled with incorrect expiration date.
| Recall number | Z-1671-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-07-10 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, JP |
| Quantity | 91 |
| Reason classes | labeling |
| Lot numbers | 091541 |
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.
Reason for recall
Product labeled with incorrect expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1671-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.