Boston Scientific recalls IntellaTip MiFi Open-Irrigated Ablation Catheters due to unapproved resin material changes that may not be reflected in product documentation.
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Boston Scientific is recalling certain IntellaTip MiFi Open-Irrigated Ablation Catheters because resin material variations occurred during manufacturing without updating their product documentation. This could lead to improper use in cardiac procedures if the catheters are not correctly identified.
The catheters were manufactured with resin materials that changed suppliers three times without updating Boston Scientific's internal documentation. This means the catheters might not be correctly identified in customer documents, potentially leading to improper use during cardiac procedures.
Patients and medical professionals using the recalled catheters for cardiac procedures. Those with the specific batch numbers listed in the recall are most at risk.
Check for the material number M004PM96200 or M004PM9620K20 or M004PM9620N40 and the specific batch numbers listed in the recall notice. The catheters are used for cardiac procedures in patients 18 years and older.
Review the material number and batch numbers listed in the recall notice to confirm if your catheter is affected.
The recall is due to resin material variations that occurred when suppliers changed three times without updating Boston Scientific's internal product documentation.
The affected batch numbers are listed in the recall notice, including M004PM96200, M004PM9620K20, and M004PM9620N40 with specific expiration dates.
No, the recall does not require immediate discontinuation. Affected users should check their product documentation to confirm if their catheter is in the recall list.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0700-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0700-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
