EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 18 units of DiamondTemp Bidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect 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 high-risk medical device where incorrect labeling could lead to serious harm (blood clots, air emboli), but no injuries or illnesses have been reported in the source text.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 18 units of the DiamondTemp Bidirectional Large Curve Ablation Catheter, 7.5 French Size (2.48 mm), Reference CEDTB400L. The recall was initiated because the catheter size indicated 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 device.
The incorrect labeling could result in blood stagnation, clots, or air emboli. The affected units were not distributed in the United States. Distribution occurred in Germany, Spain, France, Belgium, the United Kingdom, Slovenia, Italy, and Canada.
This recall applies to all lots of the specified product. Users in the affected countries should contact EPIX Therapeutics for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 18
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
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- 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
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
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