Boston Scientific recalls Opticross 35 15 MHz Peripheral Imaging Catheters with flaking markings that could cause embolization during use. Return all affected units to the manufacturer immediately.
Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
Boston Scientific is recalling Opticross 35 15 MHz Peripheral Imaging Catheters because flaking markings near the catheter shaft can detach during use. This could lead to embolization if the flaking marks advance while flushing the catheter, potentially causing serious complications during medical procedures.
The incremental telescoping length markings near the proximal end of the catheter shaft can flake off when manipulated. If these flaking marks advance while flushing the catheter, they could cause embolization, which is the blockage of blood vessels by a foreign material.
Medical professionals using the Opticross 35 catheter for ultrasound examinations are most at risk. Patients undergoing procedures with this device could experience complications if the flaking marks cause embolization.
Check for the Opticross 35 15 MHz Peripheral Imaging Catheter with expiration dates between June 8, 2021 and July 22, 2021. Look for lot numbers: 25754545, 25852104, 2582106, or 25856700.
Discontinue use of the recalled Opticross 35 catheter if you have it.
Send all affected units to Boston Scientific for proper disposal.
The recall states that embolization could occur if flaking marks advance while flushing the catheter, which might lead to serious complications. No patient harm has been reported to date.
Check for expiration dates between June 8, 2021 and July 22, 2021, and lot numbers: 25754545, 25852104, 2582106, or 25856700.
Yes, the recall states all affected devices should be returned to Boston Scientific for proper disposal.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0181-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0181-2021 from Boston Scientific. 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.
