Boston Scientific recalls certain Guider Softip Guide Catheters 6F PRE-SHAPED 40 90CM with incorrect tip curve shape. Affected units have specific lot numbers; contact for remedy.
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 specific lots of Guider Softip Guide Catheters 6F PRE-SHAPED 40 90CM due to an incorrect tip curve shape. This could lead to improper function during medical procedures, potentially causing complications for patients.
The catheters have a tip curve shape that differs from what is labeled. This could cause the catheter to behave unpredictably during medical procedures, potentially leading to complications like vessel damage or improper placement.
Healthcare professionals using the catheters for cardiac procedures are most likely affected. Patients receiving these catheters during procedures may be at risk if the incorrect tip curve causes improper guidance.
Check for the catalog number H965100420 and lot numbers listed in the recall notice. The affected units were sold with specific lot numbers including 25651700 through 28795037.
Identify the catalog number H965100420 and lot numbers from the list provided in the recall notice.
Certain lots have an incorrect tip curve shape compared to the labeled design, which could lead to unpredictable behavior during medical procedures.
Affected lot numbers include 25651700, 25651701, 25651702, 25651703, 25651704, 25651705, 25651706, 25651708, 25651709, 25651710, 25651711, 25761340, and other specific numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required unless you have the affected lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0009-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0009-2024 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.
