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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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.
Related recalls
Same manufacturer · Stryker Neurovascular
See all →- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighTrevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
FDA (Devices) · 2024-10-16
- HighStryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk
FDA (Devices) · 2024-06-12
- HighSynchro SELECT Guidewires may have PTFE coating damage
FDA (Devices) · 2024-06-12
- HighSynchro2 Guidewires: PTFE coating damage from improper backloading technique
FDA (Devices) · 2024-06-12
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect
FDA (Devices) · 2018-08-08
- HighStryker Recalls Guider Guide Catheters Due to Manufacturing Defect
FDA (Devices) · 2016-11-09
- SevereStryker Neurovascular Recalls Guider Softip XF Guide Catheters
FDA (Devices) · 2016-11-09
- HighStryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
FDA (Devices) · 2016-11-09
- HighStryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
FDA (Devices) · 2016-11-09
- ModerateStryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors
FDA (Devices) · 2013-12-25