Boston Scientific recalls Capio RP sutures model M0068321010 due to potential breakage or detachment during open surgery. Affected units have specific batch numbers and UDI.
Potential for Capio sutures to break and /or detach.
Boston Scientific is recalling Capio RP sutures model M0068321010 that may break or detach during open surgery. This could lead to complications if the sutures become dislodged from tissues.
The sutures may break or detach during surgery, which could cause tissue damage or require additional surgical intervention. This risk occurs when the sutures are under tension during tissue placement.
Surgical teams using the Capio RP sutures during open procedures are most at risk. Patients undergoing surgery with these sutures could face complications if the sutures break or detach.
Check for the model number M0068321010 on the suture packaging. Affected units have specific batch numbers listed in the recall notice and a unique device identifier (UDI) of 08714729470212.
Look for the model number M0068321010 and the listed batch numbers on the suture packaging.
The recall is due to potential breakage or detachment of Capio RP sutures during open surgery, which could cause tissue damage or require additional surgical intervention.
Affected batch numbers include 17813516, 18653139, 19987270, 18014753, 18886132, 20278129, 18015797, 19173287, 20604455, 18015964, 19335466, 20844362, 18234939, 19491590, 21178815, 18237323, 19693866, 21227473, 21386746.
Check the suture packaging for the model number M0068321010 and the specific batch numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1621-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1621-2018 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.