Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1671-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-05-28 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1671-2013
Date of alert: 2013-05-28
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices

Reported risk: Product labeled with incorrect expiration date.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1671-2013 — 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.

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