Boston Scientific Recalls Rigiflex Balloon Dilator for Incorrect Expiration Date
Boston Scientific is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator because they were labeled with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation error (incorrect expiration date) rather than a physical defect or contamination.
Plain-English summary
Boston Scientific Corporation is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator, Material Number M00554510. The recall was initiated because the product was labeled with an incorrect expiration date.
The affected product is indicated for the dilatation of the cardia in patients with achalasia. The recall covers units distributed worldwide, including nationwide in the United States and in various international locations.
Consumers and healthcare providers should stop using the affected product and contact Boston Scientific Corporation for further instructions.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Batch Number: 091541
Distribution
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