Unipolar Adapter 5 Mm, Unipolar Adapter 6mm, Bi Polar Adapter, Cap And Sleeve Kit, And Bipolar Lead, 25cm, Bipolar Lead 54cm (2018-08-31)

Recall Summary Boston Scientific is recalling several neurostimulation adapters and leads distributed across Canada because they may not function properly due to manufacturing defects. The recalled products include unipolar adapters (5mm and 6mm), bipolar adapters, cap and sleeve kits, and bipolar leads in two lengths (25cm and 54cm). These devices are used in neurostimulation systems and were distributed in Canada starting in 2018.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-09-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0a2aa448-4a14-4204-b80f-b8509e9357db