CLASS I Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
CSI Cardiovascular Systems, Inc. recalled
Cardiovascular Systems is recalling CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, distributed nationwide in the US. The recall was initiated on 23 May 2014 and the FDA has classified it as Class I.
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-2155-2014
- FDA event ID
- 68806
- Recalling firm
- Cardiovascular Systems, Saint Paul, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 May 2014
- FDA classified
- 14 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 23 May 2014 | Recall initiated by company | |
| 14 Aug 2014 | Classified by FDA | +83 days |
| 20 Aug 2014 | Published in enforcement report | +6 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 the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Product as listed by the FDA
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy 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. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Where it was distributed
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
Nationwide ArkansasArizonaCaliforniaConnecticutFloridaIowaIllinoisMarylandMichiganNorth CarolinaNew YorkPennsylvaniaTennesseeTexas
Questions about this recall
Why was it recalled?
CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Which lots are affected?
100573, 100575, 100674, 100676, 100678, 100680.
Where was it sold?
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Cardiovascular Systems
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Wirion Embolic Protection System, Delivery Catheter recalled | Cardiovascular Systems | Other | 37 states |
| Device | CLASS II | Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled | Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
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