EPIX Therapeutics recalls DiamondTemp Unidirectional Large Curve Ablation Catheters due to incorrect size labeling on packaging and instructions, which could cause blood stagnation, clots, or air emboli.
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 Large Curve Ablation Catheters because the packaging and instructions show the wrong size. This could lead to blood stagnation, clots, or air emboli 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 emboli during medical procedures.
Patients undergoing cardiac ablation procedures who use this catheter are affected. Medical professionals using the catheter for treatment are at risk of complications.
Check for the DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size (2.48 mm), with ODU 19 PIN connector. All lots are affected.
Verify the catheter's size and connector type against the packaging and instructions to confirm if it matches the correct specifications.
The recall indicates the size labeling is incorrect, which could lead to complications like blood stagnation or clots. It is not safe to use without verifying the correct specifications.
The official recall does not specify a remedy, so check the product details to ensure it matches the correct specifications before use.
Look for the DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size (2.48 mm), with ODU 19 PIN connector. All lots are affected.
We’ve drafted a message you can send EPIX Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1318-2021 — EPIX Therapeutics EPIX Therapeutics Hello, I own a EPIX Therapeutics that is covered by recall Z-1318-2021 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.
