EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 harm (blood clots or air emboli), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 60 units of the DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size (2.48 mm), REF: CEDT200L. The recall involves all lots of the product, which is sterile and packaged with an ODU 19 PIN connector.
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. This discrepancy 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. Users should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 60
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 DiamondTemp Catheter Recalled for 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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