Abbott Vascular recalls Dragonfly OpStar Imaging Catheters with potential for proximal marker separation. Affected models include REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO. Contact Abbott for details.
There is a potential that the proximal marker may separate from the imaging catheter
Abbott Vascular is recalling Dragonfly OpStar Imaging Catheters that may have a proximal marker that separates from the catheter. This could lead to improper imaging during medical procedures. Affected units include specific model numbers and lots.
The proximal marker may separate from the imaging catheter during use, which could cause the catheter to become unstable or misaligned. This might lead to inaccurate imaging results or complications during medical procedures.
Healthcare professionals using the Dragonfly OpStar Imaging Catheter for medical procedures are most at risk. Patients receiving these catheters during procedures may be affected if the catheter is recalled.
Check for the model numbers 1014651 or 1014652 with specific lot numbers listed in the recall notice. The catheter is sterile and has dimensions of 0.068 inches, 0.014 inches, and 135 cm.
Identify the model number (1014651 or 1014652) and lot numbers listed in the recall notice.
Reach out to Abbott Vascular for further instructions on how to handle the recalled catheter.
The proximal marker may separate from the imaging catheter, which could lead to improper imaging during medical procedures.
Model 1014651 and 1014652 with specific lot numbers listed in the recall notice.
Check for model numbers 1014651 or 1014652 with the lot numbers provided in the recall notice.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1095-2022 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1095-2022 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.
