Cook recalls Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications.
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Cook is recalling certain models of Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because the sheath may separate during use, potentially causing serious injury or death. This recall affects medical devices used in vascular procedures.
The introducer sheath can separate at the connection point during use. If separation happens, it may lead to blocked blood flow to vital organs, vessel damage, or bleeding, which can be life-threatening.
Medical professionals who use these devices during vascular procedures are at risk. Patients undergoing procedures with the recalled introducers could face life-threatening complications if separation occurs.
Check the lot numbers listed in the recall notice: 10332622, 10332623, 10335453, 10335456, 10338048, and other specific numbers provided in the recall. These devices were sold with the model RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC.
Discontinue use of the recalled Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with the specified lot numbers to prevent potential separation and life-threatening complications.
The recalled device is the Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with model RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC.
The affected lot numbers include 10332622, 10332623, 10335453, 10335456, 10338048, and other specific numbers listed in the recall notice.
If separation occurs, it could result in life-threatening events such as blocked blood flow to vital organs, vessel injury, or bleeding.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0611-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0611-2021 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.
