Reported Dec 7, 2016 · Terminated
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Spectranetics Corporation · 9965 Federal Drive · Colorado Springs, CO · 80921-3617
Is this the product you have?
- ELCA Coronary Atherectomy Catheter
- Models110-001, 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
- Lot codes and dates
41 of 41 products
Products covered by this recall # Product as published 1 FDD16D20A 2 FDD16E02A 3 FBM16D15B 4 FBM16F17A 5 FHH16D05B 6 FHH16G13A FHH16D12A 7 FHH16G22A 8 FHH16D19A 9 FHH16H05A 10 FHH16D26A 11 FHH16H08C FHH16D27A 12 FHH16H12A 13 FHH16E03A 14 FHH16H15A 15 FHH16E13A 16 FHH16H17A FHH16E16A 17 FHH16H24A 18 FHH16F03A 19 FHH16H29A 20 FHH16F07A - Amount recalled
- 3,141 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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