Z-1290-2015Class I

Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to...

Name: Z-1290-2015 Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to...
Creator: Cardiovascular Systems, Inc.
Published: 2015-03-04
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2015-03-04 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems, Inc. began a recall of Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary... on 2015-03-04. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1290-2015
Classification: Class I
Status: Terminated
Initiated: 2015-03-04
Posted: 2015-03-20
Terminated: 2016-04-26
Recalling firm: Cardiovascular Systems Incorporated
Product: 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.
Product code: MCX Catheter, Coronary, Atherectomy
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent on 3/4/2015 a CSI "Urgent Medical Device Recall" letter dated March 04, 2015. The letter described the problem and the affected product. Consignees were advised to remove and return the affected product to CSI. The letter also requested consignees to complete and return the Customer Acknowledgement Form by Fax or with the RGA (Returned Goods Authorization). For further information they can contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton, MN 55112, 877-274-0901 -Tel, 612-677-3355- Fax.
Quantity in commerce: 30
Distribution: Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
Product codes and lots: 107046, 106992, 106993, 106990.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1290-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1290-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-20

Product code MCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)