Spectranetics Recalls ELCA Coronary Atherectomy Catheters Due to Packaging Integrity
Spectranetics is voluntarily recalling ELCA Coronary Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a packaging integrity issue with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Spectranetics Corporation has announced a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon. The recall is being conducted due to potentially compromised integrity of the outer sterile packaging for these medical devices.
The affected ELCA Coronary Atherectomy Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System. They 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.
The recall involves 3,141 units distributed worldwide, including the United States (nationwide and Puerto Rico) and various international locations. Specific lot codes are listed in the structured product information. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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 art
- Manufacturer
- Spectranetics Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 3,141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- FDD16D20A
- FDD16E02A
- FBM16D15B
- FBM16F17A
- FHH16D05B
- FHH16G13A FHH16D12A
- FHH16G22A
- FHH16D19A
- FHH16H05A
- FHH16D26A
- FHH16H08C FHH16D27A
- FHH16H12A
- FHH16E03A
- FHH16H15A
- FHH16E13A
- FHH16H17A FHH16E16A
- FHH16H24A
- FHH16F03A
- FHH16H29A
- FHH16F07A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Spectranetics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Spectranetics Corporation
See all →- CriticalVascular Tack Endovascular System recalled for deployment and migration risks
FDA (Devices) · 2025-02-26
- HighLaser Atherectomy Catheter Recalled for Marker Band Detachment Risk
FDA (Devices) · 2024-12-25
- ModerateSpectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch
FDA (Devices) · 2023-12-20
- HighPhilips Laser System may enter non-recoverable error state
FDA (Devices) · 2022-11-23
- ModeratePhilips LAS-100 Laser System may not operate due to detected hardware failure
FDA (Devices) · 2022-07-20
Same hazard · packaging integrity
See all →- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 8-10mm 240cm Medical Device Recall Notice
FDA (Devices) · 2026-07-08
- LowPopping Boba RTD Peach Oolong Tea recalled for packaging integrity
FDA (Food) · 2026-04-08
- LowPopping Boba RTD Strawberry Dragon Fruit Oolong Tea packaging integrity issue
FDA (Food) · 2026-04-08
- LowPopping Boba Ready-to-Drink Mango Passion Fruit Green Tea Recall
FDA (Food) · 2026-04-08