CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report
CSI Stealth 360-degree Orbital Atherectomy Device (OAD) recalled
Cardiovascular Systems is recalling CSI Stealth 360-degree Orbital Atherectomy Device (OAD), distributed nationwide in the US. The recall was initiated on 18 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1959-2012
- FDA event ID
- 62406
- Recalling firm
- Cardiovascular Systems, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2012
- FDA classified
- 9 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Jun 2012 | Recall initiated by company | |
| 9 Jul 2012 | Classified by FDA | +21 days |
| 18 Jul 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
Nationwide CaliforniaFloridaIllinoisMichiganMinnesotaPennsylvaniaTexas
Questions about this recall
Why was it 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 lots are affected?
Lot s: 59887, 59888, 61516, and 61517.
Where was it sold?
Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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