Reported Dec 7, 2016 · Terminated
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159,…
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?
- Turbo Elite Atherectomy Catheter
- Models410-152, 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
- Lot codes and dates
81 of 81 products
Products covered by this recall # Product as published 1 FBD16D01A 2 FBD16F20A 3 FBD16D11A 4 FBD16F29A 5 FBD16D14A 6 FBD16G18A 7 FBD16D23A 8 FBD16G29A 9 FBD16E05A 10 FBD16H03A 11 FBD16E11A 12 FBD16H26A FBD16E19A 13 FBD16J06A 14 FBD16E26A 15 FBD16J21A 16 FBD16F03A 17 FBD16J26A 18 FBE16C30A 19 FBE16H24A 20 FBE16E25A - Amount recalled
- 14,624 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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