Boston Scientific recalls IntellaNav MiFi Open-Irrigated Ablation Catheters due to unapproved resin material changes that may not be reflected in product documentation. Affected units include specific batch numbers with expiration dates.
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 IntellaNav MiFi Open-Irrigated Ablation Catheters because supplier changes caused resin material variations not documented in their product specifications. This could lead to improper use in cardiac procedures if the catheters are not correctly identified.
The supplier changed resin sub-suppliers three times without informing Boston Scientific, causing slight variations in resin material that weren't updated in the company's internal product documentation. This means the catheter might not meet the required specifications for cardiac procedures.
Cardiac patients undergoing electrophysiological procedures with the IntellaNav MiFi catheter. Medical professionals using the catheter for atrial flutter or fibrillation treatments are most at risk.
Check for the material number M004R96200 and batch numbers 22208397 (exp 6/4/2021), 22389516 (exp 7/16/2021), or 22525798 (exp 2/14/2020). The catheter is used for cardiac electrophysiological mapping and ablation procedures.
Identify the material number M004R96200 and batch numbers listed in the recall notice.
The supplier changed resin sub-suppliers three times without notifying Boston Scientific, causing resin material variations not reflected in their internal product documentation.
Batches 22208397 (exp 6/4/2021), 22389516 (exp 7/16/2021), and 22525798 (exp 2/14/2020).
The recall notice does not specify a remedy, so no action is required beyond checking product details.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0701-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0701-2019 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.
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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.
