Recall Z-0661-2017— Spectranetics Corporation

Name: FDA recall Z-0661-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-31

Class II · Terminated

Class II FDA medical device recall by Spectranetics Corporation, initiated 2016-10-31, terminated 2017-04-18. It names one FDA 510(k) clearance: K140775. Product: Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 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.. Reason: 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..

Recalling firm: Spectranetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Terminated: 2017-04-18
Firm location: Colorado Springs, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K140775 — TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEMSpectranetics Corporation·cleared 2014-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.