Applied Medical Resources recalls Python Embolectomy Catheters due to tip separation during use, potentially exposing patients to unintended dislodgement. Affected models and lots listed in the recall.
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Applied Medical Resources is recalling Python Embolectomy Catheters because they can separate during use, which might cause the tip to dislodge from the body of the catheter. This poses a risk to patients during medical procedures.
The catheters can separate during use, potentially causing the tip to dislodge from the body. This could lead to unintended dislodgement of the tip from the patient's body during medical procedures, risking complications.
Medical professionals using these catheters for procedures are most at risk. Patients undergoing treatments with the recalled models could face complications if the catheter tip separates.
Check for model numbers A4E01 through A4E09 with specific lot numbers listed in the recall. The catheters are sterile, CE marked, and come in different lengths (5mm-40cm to 14mm-80cm).
Immediately stop using any Python Embolectomy Catheters with the listed model numbers and lot numbers to prevent potential tip separation.
Affected models include A4E01 (5mm-40cm), A4E02 (5mm-80cm), A4E03 (9mm-40cm), A4E04 (9mm-80cm), A4E05 (11mm-40cm), A4E06 (11mm-80cm), A4E08 (13mm-80cm), and A4E09 (14mm-80cm) with specific lot numbers listed in the recall.
The recall does not mention a fix; the remedy is null, so users should stop using the affected catheters immediately.
Check the model number and lot number on the catheter packaging against the list provided in the recall. The catheters are sterile, CE marked, and come in different lengths.
We’ve drafted a message you can send Applied Medical Resources to request your refund or repair — edit it as you like.
Subject: Recall Z-1846-2020 — Applied Medical Resources Applied Medical Resources Hello, I own a Applied Medical Resources that is covered by recall Z-1846-2020 from Applied Medical Resources. 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.