Abbott Vascular recalls MitraClip XTR and G4 Clip Delivery Systems due to increased clip locking malfunctions that could cause severe heart problems during cardiac procedures.
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Abbott Vascular is recalling specific MitraClip XTR and G4 clip delivery systems because they may lock incorrectly during heart procedures, risking severe heart problems like device embolization or tissue injury.
The clip delivery systems can lock incorrectly during heart procedures, which might lead to unsuccessful surgery. This could cause severe mitral regurgitation, device embolization, or tissue injury if the clip doesn't function properly.
Patients undergoing cardiac procedures with the recalled MitraClip systems are most at risk. Healthcare providers using these devices for heart surgery may also be affected.
Check for the model numbers: CDS0601-XTR, CDS0701-NT, CDS0701-NTW, CDS0701-XT, or CDS0701-XTW on the device. These systems were used in cardiac procedures and sold with specific lot numbers.
Look for the model number on the device to confirm if it's a recalled version.
The recall is due to increased clip locking malfunctions that could lead to severe mitral regurgitation, device embolization, or tissue injury during heart procedures.
The official recall notice does not specify a remedy or action steps for affected devices.
Yes, check for model numbers: CDS0601-XTR, CDS0701-NT, CDS0701-NTW, CDS0701-XT, or CDS0701-XTW on the device.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0115-2023 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-0115-2023 from Abbott Vascular. 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.
