EPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors
EPIX Therapeutics is recalling 13 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 result in serious harm (blood clots or air emboli), but no injuries or illnesses have been reported, 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 13 units of the DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size (2.48 mm), Reference DT200L. The recall was initiated because the catheter size listed on the packaging labeling does not correspond to the widest part of the catheter, and the Instructions for Use (IFU) contain the incorrect diameter of the catheter.
The product was not distributed in the United States. It was distributed in Germany, Spain, France, Belgium, the United Kingdom, Slovenia, Italy, and Canada. The source text does not specify which lots are affected, though the structured data indicates "All Lots."
The incorrect labeling could result in blood stagnation, clots, or air emboli. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 13
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
See all →- 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
- 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
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
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