Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents
Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.
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 involves a risk-of-harm medical device where injury has not yet been reported, fitting the High severity criteria for theoretical risk without confirmed adverse events.
Plain-English summary
Cook Inc. is recalling 10 units of the Formula 418 Renal Balloon-Expandable Stent, Order Number G56611, Lot 10153876. The recall is due to reports that the stent dislodged from the balloon delivery system prior to deployment.
The affected devices were distributed domestically to Ohio, Iowa, Virginia, and North Carolina, as well as to Canada. The stent is made of 316L stainless steel and is pre-mounted on an over-the-wire balloon catheter.
Use of the affected product may lead to increased procedural time and the need for additional intervention to remove a stent that has dislodged within an unintended location. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. Th
- Manufacturer
- Cook Inc.
- Affected units
- 10
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 number 10153876
Distribution
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