EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 100 units of DiamondTemp Unidirectional Small Curve Ablation Catheters because packaging and instructions list incorrect catheter 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 is classified as FDA Class II. The source text identifies a risk of serious harm (blood stagnation, clots, or air emboli) due to labeling errors, but does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 100 units of the DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), Reference CEDT100S. The recall affects all lots of this specific sterile, ethylene oxide-sterilized device.
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 for the catheter. These labeling discrepancies could result in blood stagnation, clots, or air emboli during use.
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 in these regions should verify the physical dimensions of the catheter against the device itself rather than relying solely on the packaging or IFU, and should contact the manufacturer for further guidance.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 100
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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