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 stagnation, clots, or air embolisms during medical procedures.
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 air embolisms during medical procedures.
Medical professionals using the catheter for procedures are affected. Patients receiving the catheter as part of their treatment may be at risk if the incorrect size causes complications.
Check for the DiamondTemp Unidirectional Ablation Catheter, Large 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 if it matches the 7.5 French size with ODU 19 PIN connector.
The recall indicates the labeling does not match the actual size, which could cause blood stagnation or clots. It is not safe to use without verifying the correct size.
Look for the DiamondTemp Unidirectional Ablation Catheter, Large 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 with your healthcare provider or EPIX Therapeutics for guidance on next steps.
We’ve drafted a message you can send EPIX Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1322-2021 — EPIX Therapeutics EPIX Therapeutics Hello, I own a EPIX Therapeutics that is covered by recall Z-1322-2021 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.
