Device recall: CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage…
Class III FDA enforcement event 67445. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Cardiovascular Systems, Inc. started this device recall on 27 Jan 2014. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class III. FDA event 67445 has 1 product record. The first FDA enforcement report date is 5 Mar 2014. The record gives the status Terminated, with the termination date 5 May 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
Recalling firm
Cardiovascular Systems, Inc., Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1095-2014 | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: 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… | 318 | Class III | Terminated | 5 Mar 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class III
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 13
Other events of the firm
Official channels
- FDA enforcement report Z-1095-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67445. https://recallregister.com/fda/iii/67445/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
- What quantity of product is in FDA event 67445?
- The FDA record gives this quantity:
318
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 4% of the 1,176 device events that started in 2014 are in Class III.