CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Amplatzer Steerable Delivery Sheath recalled by Abbott

Abbott is recalling Amplatzer Steerable Delivery Sheath. The recall was initiated on 9 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741

Quantity recalled529 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0895-2022
FDA event ID: 89714
Recalling firm: Abbott, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 9 Nov 2021
FDA classified: 7 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Nov 2021	Recall initiated by company
7 Apr 2022	Classified by FDA	+149 days
13 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Instructions for use were updated.

Product as listed by the FDA

Amplatzer Steerable Delivery Sheath

Where it was distributed

OUS distribution only

Questions about this recall

Is Amplatzer Steerable Delivery Sheath recalled?

Yes. Abbott recalled Amplatzer Steerable Delivery Sheath on 9 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0895-2022.

Why was it recalled?

Instructions for use were updated.

Which lots are affected?

Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741

Where was it sold?

OUS distribution only

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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