Boston Scientific recalls unapproved PROPONENT VDD SL pacemakers (Model L209) due to intermittent over-sensing of Minute Ventilation sensor signals. This may cause improper heart rhythm management. Affected devices were not approved for U.S. use.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Boston Scientific is recalling unapproved PROPONENT VDD SL pacemakers (Model L2:09) because they may cause improper heart rhythm management due to intermittent over-sensing of Minute Ventilation sensor signals. This recall applies to devices not approved for U.S. use.
The pacemaker may incorrectly interpret Minute Ventilation sensor signals, leading to improper heart rhythm management. This could cause the device to malfunction without warning, potentially affecting heart function.
Pacemaker users in the U.S. who own the unapproved PROPONENT VDD SL pacemaker (Model L209) are affected. Those with medical devices not approved for U.S. use are at risk.
Check if your pacemaker is labeled 'PROPONENT VDD SL' with model number L209. These devices were not approved for use in the United States.
Verify if your pacemaker is labeled 'PROPONENT VDD SL' with model number L209.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation sensor signal with certain pacemakers, which may cause improper heart rhythm management.
No, these devices were not approved for use in the United States.
Check if your pacemaker is labeled 'PROPONENT VDD SL' with model number L209. These devices were not approved for U.S. use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0376-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0376-2018 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.
