Faradrive Steerable Sheath

FARADRIVE Steerable Sheath Recall Summary Boston Scientific is recalling FARADRIVE Steerable Sheath devices (multiple models and lots) used in hospitals and pharmacies in New Zealand because improper insertion of the dilator during device preparation can damage the hemostatic valve, potentially allowing air to enter the device. This air ingress could lead to air embolism and patient harm. The manufacturer is updating instructions and making manufacturing changes to reduce this risk.

Recalling firm

Boston Scientific NZ Ltd

Product

FARADRIVE Steerable Sheath. [Device]. Model: UPN - 21M402 - FARADRIVE STEERABLE SHEATH CLEAR; UPN - M004PF21M402 - FARADRIVE STEERABLE SHEATH (CLEAR) - US; UPN - M004PFCE21M402 - FARADRIVE STEERABLE SHEATH CLEAR OUS. Affected: Multiple Lots; Multiple Lots; Multiple Lots. Also covers: FARADRIVE Steerable Sheath (US); FARADRIVE Steerable Sheath

Reason

The manufacturer complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body., Although FARADRIVE is performing within performance expectations and published guidance, the manufacturer has implemented manufacturing updates and is...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-06-11

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/ed859696-9c65-4180-b030-961366059681