EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 15 DiamondTemp Bidirectional Small Curve Ablation Catheters because the packaging and instructions for use list incorrect catheter sizes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (blood stagnation, clots, or air emboli) due to labeling errors, but no injuries or illnesses have been reported.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 15 units of the DiamondTemp Bidirectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), REF: CEDTB300S. The recall was initiated because the catheter size indicated on the packaging labeling does not correspond to the widest part of the catheter. Additionally, the Instructions for Use (IFU) contain the incorrect diameter of the catheter.
The FDA has classified this recall as Class II. The incorrect labeling could result in blood stagnation, clots, or air emboli. The product was not distributed in the United States. It was distributed in Germany, Spain, France, Belgium, the United Kingdom, Slovenia, Italy, and Canada.
Healthcare providers and patients who have received this product should contact EPIX Therapeutics, Inc. for further instructions. The recall number is Z-1319-2021.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 15
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 (1)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by EPIX THERAPEUTICS, INC 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 6 products in this recall →Related recalls
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