Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published November 9, 2021

Abbott Amplatzer Steerable Delivery Sheath Recall: Updated Instructions

Abbott recalls specific Amplatzer Steerable Delivery Sheath models due to updated instructions for use. Affected units include batch numbers 7963817 to 8277741. Consumers should check their product details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0895-2022Medical deviceAbbott ›
Take action

Contact the company

Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209
✎ GovInfoNow plain-language explainer

Abbott is recalling certain Amplatzer Steerable Delivery Sheaths because their instructions for use were updated. This recall does not involve a safety hazard but requires users to follow the new instructions to ensure proper use. Read more at govinfonow.com/recall/61555-abbott-amplatzer-steerable-delivery-sheath-recall-updated-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/61555-abbott-amplatzer-steerable-delivery-sheath-recall-updated-instructions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0895-2022

Cite this page

“Abbott Amplatzer Steerable Delivery Sheath Recall: Updated Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61555-abbott-amplatzer-steerable-delivery-sheath-recall-updated-instructions. Based on FDA recall #Z-0895-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2022%22&limit=1).

The FDA announced on 2021-11-09 that Abbott voluntarily recalled Amplatzer Steerable Delivery Sheaths because instructions for use were updated, GovInfoNow reports.

How to tell if you have it

  • Brand: Abbott
  • Product: Amplatzer Steerable Delivery Sheath
  • Model: ASDS-14F-075
  • Batch Numbers: 7963817, 7976534, 7981029, 7990340, 8008111, 8010056, 8025120, 8102214, 8106240, 8234848, 8274323, 8277741
  • Units affected: 529

The hazard

The recall was issued because the instructions for use were updated, according to the FDA.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since 2018-04-05. Other recent recalls of similar products include Arrow Percutaneous Sheath Introducer Recall (2026-03-11), Abiomed Intro Kit Recall (2026-06-11), and Abiomed Heart Pump Kit Recall (2026-06-11).

How to tell if you have this one

Check the model number on the sheath, which is ASDS-14F-075. Look for batch numbers listed: 7963817, 7976534, 7981029, 7990340, 8008111, 8010056, 8025120, 8102214, 8106240, 8234848, 8274323, or 8277741.

  • Brand
    Abbott
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the model number and batch numbers to confirm if your Amplatzer Steerable Delivery Sheath is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Nov 9, 202112. FDA classified it Class II: Apr 7, 202223. Published in FDA’s Enforcement Report: Apr 13, 202234. FDA terminated the recall: Aug 7, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0895-2022 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0895-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA