Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2012
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous trans
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may resul…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardiovascular Systems, Inc. recalled CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Numb… - a moderate-severity action.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Numb… was recalled by Cardiovascular Systems, Inc. in July 18, 2012. Reason: CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which h…. Check the official notice for the remedy. Verify recall #Z-1959-2012 with the FDA Devices before acting.
The recall
Cardiovascular Systems, Inc. issued this moderate-severity FDA Devices recall-CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which h….
- Moderate
- severity level
- 27 units
- affected scope
- Class II
- classification
- July 18, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1959-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1959-2012) was formally reported on July 18, 2012, with the manufacturer initiating the action on June 18, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardiovascular Systems, Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 27.
The documented reason for this recall is: CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from th… Distribution data in the federal record shows the product reached: Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.. 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
27
Related Recalls
6
3 from same agency
Product description
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Reason for recall
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1959-2012 |
| Date reported | July 18, 2012 |
| Date initiated | June 18, 2012 |
| Recalling firm | Cardiovascular Systems, Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 27 |
| Distribution | Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX. |
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-1959-2012) 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? ▼
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.. Recalled by Cardiovascular Systems, Inc.. Units affected: 27.
Why was this product recalled? ▼
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1959-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1959-2012) 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 July 18, 2012. 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.