EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 19 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.
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 involves a medical device with a labeling error that could lead to serious physiological complications such as blood clots or air emboli, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 19 units of the DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size (2.48 mm). The recall involves all lots of the product, which is sterile and requires a prescription. The product was not distributed in the United States but was distributed in Germany, Spain, France, Belgium, the United Kingdom, Slovenia, Italy, and Canada.
The recall was initiated because the catheter size listed 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. This discrepancy could result in blood stagnation, clots, or air emboli.
Healthcare providers and patients who have received these specific catheters should stop using them and contact EPIX Therapeutics for further instructions.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 19
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
Same manufacturer · EPIX THERAPEUTICS, INC
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- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
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