EPIX Therapeutics recalls DiamondTemp Unidirectional Ablation Catheters due to incorrect size labeling on packaging and instructions, which may cause blood stagnation or clots. Affected units include all lots of the 7.5 French size catheter.
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
EPIX Therapeutics is recalling DiamondTemp Unidirectional Ablation Catheters because the packaging and instructions list an incorrect size. This could lead to blood clots or air embolisms if the catheter is used improperly.
The catheter's size on the packaging and instructions does not match the actual widest part. This mismatch could cause blood to stagnate, form clots, or lead to air embolisms during medical procedures.
Healthcare professionals who use the catheter for medical procedures are most at risk. Patients receiving the catheter as part of their treatment may also be affected.
Check for the DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size (2.48 mm) with ODU 19 PIN connector. All lots of this product are affected.
Verify the catheter's size and connector type against the packaging and instructions to confirm it matches the 7.5 French size with ODU 19 PIN connector.
The recall indicates the labeling is incorrect, which could lead to blood clots or air embolisms. It is not safe to use without verifying the correct size.
Look for the DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size (2.48 mm) with ODU 19 PIN connector. All lots of this product are affected.
The recall does not specify a remedy, so check the product details to confirm if it matches the recalled specifications before use.
We’ve drafted a message you can send EPIX Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1321-2021 — EPIX Therapeutics EPIX Therapeutics Hello, I own a EPIX Therapeutics that is covered by recall Z-1321-2021 from EPIX Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
