FDA Device recall Z-0662-2017
ELCA Coronary Atherectomy Catheter
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of ELCA Coronary Atherectomy Catheter by Spectranetics, citing spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to pote….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0662-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-31 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Spectranetics |
| Distribution | US |
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.
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.
Identifiers
| code_info | FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2017%22
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