ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
FDA Recall Z-0662-2017 · Posted 2016-11-28
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Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeLPC
Date Initiated2016-10-31
Date Terminated2017-04-18
Product Quantity3,141 units
Reason for Recall
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Firm Action
Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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