EPIX Therapeutics recalls DiamondTemp Bidrectional Small 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 Bidrection:al Small Curve Ablation Catheters because the packaging and instructions list an incorrect 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.
Medical professionals using the catheter for procedures are most at risk. Patients receiving the catheter during medical treatments may also be affected.
Look for the DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), Connector Type: ODU. The product has a reference code CEDTB300S and is sterile.
Verify the catheter's size and connector type against the packaging and instructions.
The catheter size on the packaging and instructions does not match the actual widest part, which could cause blood stagnation, clots, or air emboli.
The official recall notice does not specify a remedy or action steps for affected users.
The recall states the risk could lead to blood stagnation, clots, or air emboli, but does not specify serious injury in normal 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-1319-2021 — EPIX Therapeutics EPIX Therapeutics Hello, I own a EPIX Therapeutics that is covered by recall Z-1319-2021 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.
