Boston Scientific recalls Guider Softip Guide Catheter 5F models with incorrect tip curve shape. These catheters may not function as intended during cardiac procedures. Affected units include specific lot numbers and catalog numbers.
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Boston Scientific is recalling certain Guider Softip Guide Catheters 5F models due to an incorrect tip curve shape. This could affect the catheter's performance during cardiac procedures. The recall involves specific lot numbers and catalog numbers.
The catheters have a tip curve shape that differs from what is labeled. This could lead to improper function during cardiac procedures, potentially affecting patient safety. However, the hazard is not described as causing serious injury in normal use.
Cardiovascular professionals and hospitals that use the Guider Softip Guide Catheter 5F models with the listed lot numbers are most at risk. The recall affects specific medical devices used in cardiac procedures.
Check the catalog number M003101620 and lot numbers listed: 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896.
Verify the catalog number M003101620 and lot numbers listed in the recall notice.
The catheters have a tip curve shape that differs from the labeled shape, which could affect their function during cardiac procedures.
Affected lot numbers include 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896.
The recall does not specify a stop-use action; the hazard is described as low risk and does not require immediate discontinuation.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0023-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0023-2024 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.
