Reported Mar 5, 2014 · Terminated
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage:…
Cardiovascular Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiovascular Systems, Inc. · 651 Campus Dr · Saint Paul, MN · 55112-3495
Is this the product you have?
- CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02
- Model Number DBEC-125 Product UsageThe 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
- Lot codes and dates
- Lot
85408 -8541285585 -855878727687278872808731787462874648779387949 - 8795288520 - 8852488975 - 889798949889501- 895048995289954899569187691877918919212492156
- Lot
- Amount recalled
- 318
Where it was sold
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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