Recall Z-0662-2017

Spectranetics Corporation · initiated October 31, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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.

Codes / lots: FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A FBB16G20A; FLL16G21A; FHH16G28A; FHH16J09B

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.

FDA-determined cause: Packaging

Action taken

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.

Details

Recall number
Z-0662-2017
Initiated
October 31, 2016
Posted by FDA
November 28, 2016
Terminated
April 18, 2017
Product code
LPC – Device, Angioplasty, Laser, Coronary
Quantity
3,141 units
Distribution
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.
Recalling firm
Spectranetics Corporation, Colorado Springs, CO

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0661-2017 Class IITurbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… 10/31/2016Terminated
Z-0663-2017 Class IIBridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… 10/31/2016Terminated