Boston Scientific recalls Blazer Open-Irrigated Ablation Catheters due to unapproved resin material changes that may not be reflected in product documentation. Affected batches include specific material numbers and 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 Blazer Open-Irrigated Ablation Catheters because supplier changes in resin material compositions were not properly documented. This could lead to safety issues if the catheters are used without updated documentation.
The supplier changed resin sub-suppliers three times without informing Boston Scientific, causing slight variations in resin material that weren't updated in the product documentation. This means the catheters might not meet safety standards as intended.
Patients using Blazer catheters for cardiac procedures, particularly those with specific material numbers and batch dates listed. Medical professionals handling these catheters are most at risk.
Check for material numbers M00496200, M0049620N40, or M0049620K20 with specific batch numbers and expiration dates listed in the recall notice.
Review the material number and batch date on the catheter to see if it matches the affected batches listed in the recall.
The supplier changed resin sub-suppliers three times without notifying Boston Scientific, causing slight variations in resin material that weren't reflected in the product documentation.
Batches include 20399570 (exp 3/13/2020), 21778776 (exp 2/21/2021), 22152470 (exp 5/21/2021), 22499259 (exp 8/13/2001), 20413170 (exp 3/16/2020), 20809676 (exp 6/22/2020), and 20403945 (exp 3/13/2020).
No specific action is required beyond checking the product documentation against the listed batches and material 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-0699-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0699-2019 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.
