Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 20, 2020
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56… - a moderate-severity action.
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56… was recalled by Cook Inc. in May 20, 2020. Reason: The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon…. Check the official notice for the remedy. Verify recall #Z-1940-2020 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- May 20, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1940-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1940-2020) was formally reported on May 20, 2020, with the manufacturer initiating the action on April 15, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 10.
The documented reason for this recall is: 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 additi… Distribution data in the federal record shows the product reached: Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1940-2020 |
| Date reported | May 20, 2020 |
| Date initiated | April 15, 2020 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 10 |
| Distribution | Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1940-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 10.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1940-2020.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1940-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 20, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.