Spectranetics Recalls Turbo Elite Atherectomy Catheters Due to Packaging Integrity
Spectranetics is voluntarily recalling Turbo Elite 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 classified as FDA Class II and is a voluntary precautionary action regarding packaging integrity without reported injuries or illnesses, fitting the Moderate criteria.
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 because the integrity of the outer sterile packaging for these devices may be compromised.
The affected products are intended for use in patients with single or multivessel coronary artery disease. The Turbo Elite Atherectomy Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System. The devices are distributed worldwide, including in the United States and Puerto Rico, as well as in numerous international locations such as Austria, Belgium, Canada, and the United Kingdom.
This action involves 14,624 units. Specific lot codes are listed in the official recall documentation. Users of these medical devices should contact Spectranetics Corporation or their healthcare provider for further instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Spectranetics Corporation
- Hazard
- Affected units
- 14,624
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)
- FBD16D01A
- FBD16F20A
- FBD16D11A
- FBD16F29A
- FBD16D14A
- FBD16G18A
- FBD16D23A
- FBD16G29A
- FBD16E05A
- FBD16H03A
- FBD16E11A
- FBD16H26A FBD16E19A
- FBD16J06A
- FBD16E26A
- FBD16J21A
- FBD16F03A
- FBD16J26A
- FBE16C30A
- FBE16H24A
- FBE16E25A
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.
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