Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse
Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (tip collapse) in a medical device used in vascular procedures, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Concentric Medical Inc is recalling 13 units of FlowGate Balloon Guide Catheters. The affected devices are identified by catalog number 90253, lot number 36140, and catalog number 90254, lot numbers 36009 and 36135. These catheters are indicated for use in facilitating the insertion and guidance of intravascular catheters in the peripheral and neurovascular systems.
The recall was initiated after the firm received complaints regarding resistance and possible collapse of the distal tip of the catheters during use for aspiration. The devices were distributed nationwide in the United States, including the states of California, Florida, Georgia, Oregon, and Tennessee.
Healthcare providers and facilities should check their inventory for the specific catalog and lot numbers listed above. If the affected devices are found, they should be removed from service and returned to the manufacturer or disposed of according to the firm's instructions.
The recalled product
- Product
- FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal
- Manufacturer
- Concentric Medical Inc
- Affected units
- 13
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 (5)
- Catalog number 90253
- lot # 36140
- Catalog number 90254
- lot numbers 36009
- 36135.
Distribution
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