Formula 418 Renal Balloon-Expandable Stent — Class II medical device recall Z-1940-2020
Terminated recall by Cook Inc., reported 2020-05-20, distributed in IA, NC, OH, VA. The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon
| Recall number | Z-1940-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-04-15 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2024-04-15 |
| Distributed | IA, NC, OH, VA |
| Countries outside the US | CA |
| Quantity | 10 |
| Lot numbers | 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 with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1940-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.