Cook recalls transseptal needles with missing back bevel that could damage heart introducer during procedure. Affected models include TSNC-18-71.0 (Order G02364).
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Cook is recalling transseptal needles that lack a back bevel on the tip. This could damage the heart introducer during medical procedures, potentially causing complications.
The needles were manufactured without a back bevel on the tip. This design flaw could cause damage to the heart introducer during needle insertion, potentially leading to complications.
Healthcare professionals using these needles for heart procedures are most at risk. Patients undergoing transseptal left heart access procedures may be affected if they use recalled needles.
Check for the reference number TSNC-18-7:0 and order number G02364 on the needle packaging. The lot number 8833687 is also associated with this recall.
Look for reference number TSNC-18-71.0 and order number G02364 on the needle packaging.
The needles were manufactured without a back bevel on the tip, which could cause damage to the heart introducer during insertion.
Check for reference number TSNC-18-71.0 and order number G02364 on the packaging, or lot number 8833687.
The recall does not specify a stop-use instruction, but healthcare professionals should verify if they have the recalled model before use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0979-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-0979-2019 from Cook. 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.
