Urgent Medical Device Recall
Boston Scientific is retrieving specific pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations.
There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. However, Boston Scientific systems are dependent on unique pacemaker model/serial number combinations, so we are retrieving non-implanted inventory.
Affected Products
The affected products are Model L331 ACCOLADETM, L231 PROPONENTTM, and L131 ESSENTIOTM DR EL pacemakers with specific Material Numbers, GTIN, and Serial numbers.
Instructions for users include discontinuing use of the affected products, segregating them, and completing a Verification Form even if no products are to be returned.
Boston Scientific is not recommending routine prophylactic replacement of any affected device that may have been implanted.
Manual:
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