Cook recalls Flexor Tuohy-Borst Side-Arm Introducers with specific lot numbers due to potential sheath separation causing life-threatening events during medical procedures.
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 Flexor Tuohy-Borst Side-Arm Introducers because they may separate during use, leading to serious complications like bleeding or organ damage. This recall affects medical devices used in vascular procedures.
The introducer sheath may separate at the connection point during use. If this happens, it can cause bleeding, block blood flow to vital organs, or require emergency intervention to prevent serious injury.
Healthcare professionals using the recalled Flexor Introducers for vascular procedures are at risk. Patients undergoing procedures with these devices could face life-threatening complications if separation occurs.
Check for lot numbers: 13029776, 13050652, 13082600, 13082601, 13082603, 13101307, 13101310, 13131722, 13141048, 13141049, 13150557, 13155318, 13155322, 13179880, 13186371, 13186372, 13192133, 13211850, 13237759, 13274344. The product is used in vascular procedures by medical professionals.
Discontinue use of the recalled Flexor Tuohy-Borst Side-Arm Introducers if you have them.
The introducer sheath may separate at the connection point during use, potentially causing bleeding, blockage of blood flow to vital organs, or requiring emergency intervention.
Lot numbers: 13029776, 13050652, 13082600, 13082601, 13082603, 13101307, 13101310, 13131722, 13141048, 13141049, 13150557, 13155318, 13155322, 13179880, 13186371, 13186372, 13192133, 13211850, 13237759, 13274344.
Check the lot number on the device; affected units have specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0610-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0610-2021 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.
