Cook recalls urethral dilation balloon catheters with open tip due to risk of stiff wire guide entering patients during use. Affected models include 8494465 through 8754089 and NS85132: incorrect loading may cause injury.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Cook is recalling urethral dilation balloon catheters with open tips because the wire guide could be loaded incorrectly, potentially causing the stiff tip to enter the patient instead of the flexible tip. This risk could lead to injury during medical procedures.
The wire guide may be loaded incorrectly into the holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during medical procedures if the catheter is used improperly.
Healthcare professionals using the catheter for medical procedures are most at risk. Patients receiving the catheter during procedures may also be affected if the device is used incorrectly.
Check the product serial numbers on the device: 8494465, 8513227, 8537103, 8537104, 8552050, 8552051, 8567256, 8576963, 8632766, 8639366, 8659206, 8683459, 8754089, or NS8513228.
Verify the product serial numbers on the device: 8494465, 8513227, 8537103, 8537104, 8552050, 8552051, 8567256, 8576963, 8632766, 8639366, 8659206, 8683459, 8754089, or NS8513228.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip, which could lead to injury during medical procedures.
Check the product serial numbers: 8494465, 8513227, 8537103, 8537104, 8552050, 8552051, 8567256, 8576963, 8632766, 8639366, 8659206, 8683459, 8754089, or NS8513228.
The official recall notice does not specify a remedy or action steps beyond checking the serial numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0970-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0970-2020 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.
