Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 1, 2015
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during c…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardiovascular Systems, Inc. recalled Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The syste… - a critical-severity action.
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The syste… was recalled by Cardiovascular Systems, Inc. in April 1, 2015. Reason: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material …. Check the official notice for the remedy. Verify recall #Z-1290-2015 with the FDA Devices before acting.
The recall
Cardiovascular Systems, Inc. issued this critical-severity FDA Devices recall-The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material ….
- Critical
- severity level
- 30 units
- affected scope
- Class I
- classification
- April 1, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1290-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1290-2015) was formally reported on April 1, 2015, with the manufacturer initiating the action on March 4, 2015. It is classified under Critical severity (Class I), 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 30.
The documented reason for this recall is: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large en… Distribution data in the federal record shows the product reached: Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
30
Related Recalls
6
3 from same agency
Product description
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Reason for recall
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1290-2015 |
| Date reported | April 1, 2015 |
| Date initiated | March 4, 2015 |
| Recalling firm | Cardiovascular Systems, Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 30 |
| Distribution | Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI. |
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-1290-2015) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.. Recalled by Cardiovascular Systems, Inc.. Units affected: 30.
Why was this product recalled? ▼
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2015. Severity: Critical. Recall number: Z-1290-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1290-2015) 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 April 1, 2015. 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.