Formula 418 Renal Balloon-Expandable Stent recall
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel…
Why was Formula 418 Renal Balloon-Expandable Stent recalled?
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number 10153876
- 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…
- Recalling firm
- Cook Inc.
- Quantity
- 10
- Distribution
- Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)