Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 22, 2023
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Atrium Medical Corporation recalled Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restorin… - a moderate-severity action.
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restorin… was recalled by Atrium Medical Corporation in November 22, 2023. Reason: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.. Check the official notice for the remedy. Verify recall #Z-0291-2024 with the FDA Devices before acting.
The recall
Atrium Medical Corporation issued this moderate-severity FDA Devices recall-Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment..
- Moderate
- severity level
- 141 units
- affected scope
- Class II
- classification
- November 22, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0291-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0291-2024) was formally reported on November 22, 2023, with the manufacturer initiating the action on September 21, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Atrium Medical Corporation is listed as the recalling firm, operating out of Merrimack, NH. Federal records list the affected scope as 141 units.
The documented reason for this recall is: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Distribution data in the federal record shows the product reached: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
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
141 units
Related Recalls
6
3 from same agency
Product description
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Reason for recall
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0291-2024 |
| Date reported | November 22, 2023 |
| Date initiated | September 21, 2023 |
| Recalling firm | Atrium Medical Corporation |
| Firm location | Merrimack, NH |
| Affected scope | 141 units |
| Distribution | Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom |
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-0291-2024) 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? ▼
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361. Recalled by Atrium Medical Corporation. Units affected: 141 units.
Why was this product recalled? ▼
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0291-2024.
Where was the recalled product distributed? ▼
Distribution: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0291-2024) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 22, 2023. 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.