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Terminated

Amplatzer Steerable Delivery Sheath

FDA Recall Z-0895-2022 · Posted None

Recalling FirmAbbott
Recall StatusTerminated
Product CodeDQY
Date Initiated2021-11-09
Date Terminated2024-08-07
Product Quantity529 units

Reason for Recall

Instructions for use were updated.

Firm Action

Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible. The product is not being removed from the field and does not need to be returned. The recalling firm is providing additional instructions to reduce the potential for air ingress.

Root Cause

Device Design

Distribution Pattern

OUS distribution only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212026Amplatzer Steerable Delivery SheathABBOTT MEDICAL · 2021-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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