Stryker Neurovascular Recalls 8F Balloon Guide Catheters Due to Packaging Error
Stryker Neurovascular is recalling 190 8F Balloon Guide Catheters because they were incorrectly packaged in 9F Balloon Guide Catheter packaging. The affected lot was distributed only outside the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/packaging error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 190 units of the Merci 9F, 80cm, Balloon Guide Catheter (REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771). The recall is due to a labeling error where 8F Balloon Guide Catheters were packaged within 9F Balloon Guide Catheter packaging.
The affected lot number is 0000010779. This lot was not distributed within the United States. Distribution was limited to the Czech Republic, Italy, the Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, and Switzerland.
Healthcare providers and distributors in the affected countries should stop using the product and contact Stryker Neurovascular for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 190
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 (2)
- Lot number 0000010779
- This lot was not distributed within the US
Distribution
Distribution scope not specified by the agency.
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