Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 1, 2017
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower li
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardiovascular Systems Inc recalled DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Athere… - a moderate-severity action.
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Athere… was recalled by Cardiovascular Systems Inc in March 1, 2017. Reason: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.. Check the official notice for the remedy. Verify recall #Z-1230-2017 with the FDA Devices before acting.
The recall
Cardiovascular Systems Inc issued this moderate-severity FDA Devices recall-CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED..
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- March 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1230-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1230-2017) was formally reported on March 1, 2017, with the manufacturer initiating the action on December 7, 2016. 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 8 units.
The documented reason for this recall is: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Distribution data in the federal record shows the product reached: Nationwide Distribution to LA, MS, SC, 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
8 units
Related Recalls
6
3 from same agency
Product description
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs 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. The Stealth 360 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 discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1230-2017 |
| Date reported | March 1, 2017 |
| Date initiated | December 7, 2016 |
| Recalling firm | Cardiovascular Systems Inc |
| Firm location | Saint Paul, MN |
| Affected scope | 8 units |
| Distribution | Nationwide Distribution to LA, MS, SC, 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-1230-2017) 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? ▼
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs 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. The Stealth 360 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: 8 units.
Why was this product recalled? ▼
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1230-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to LA, MS, SC, TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1230-2017) 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 March 1, 2017. 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.