Lower risk Medical device recall · FDA · Published June 12, 2023

Abbott Amplatzer Steerable Delivery Sheath Recall: Air Embolism Risk

Abbott recalls specific models of cardiac catheters due to reported air embolism risks during procedures. Affected units have unique batch numbers and UDI/DI codes.

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

🇺🇸 FDA recall #Z-2110-2023Medical device Abbott ›

Lower-risk recall

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Take action

Contact the company

Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209

✎ GovInfoNow plain-language explainer

Abbott is recalling certain cardiac catheters (ASDS-14F-075) because they have been linked to air embolism incidents during medical procedures. This risk could potentially cause serious complications for patients undergoing cardiac treatments. Read more at govinfonow.com/recall/57868-abbott-amplatzer-steerable-delivery-sheath-recall-air-embolism-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57868-abbott-amplatzer-steerable-delivery-sheath-recall-air-embolism-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2110-2023

Cite this page

“Abbott Amplatzer Steerable Delivery Sheath Recall: Air Embolism Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57868-abbott-amplatzer-steerable-delivery-sheath-recall-air-embolism-risk. Based on FDA recall #Z-2110-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2023%22&limit=1).

The FDA announced on June 12, 2023, that Abbott is voluntarily recalling the Abbott Amplatzer Steerable Delivery Sheath (ASDS) due to a risk of air embolism. The agency issued recall number Z-2110-2023 for the Class I device.

How to tell if you have it

Brand: Abbott
Product: Abbott Amplatzer Steerable Delivery Sheath (ASDS)
REF: ASDS-14F-075
UDI/DI: 05415067036025
Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Quantity: 675 units

The hazard

According to the FDA, there is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Other recent recalls of similar products include Abbott TactiFlex Sensor Catheter Recall: Tip Detachment Risk (Sept. 10, 2025) and Abbott Amplatzer TorqVue LP Delivery System Recall: Risk of Blood Loss or Air Embolism (March 17, 2025). Other recent recalls of similar products include Boston Scientific FARADRIVE Steerable Sheath Recall: Risk of Air Embolism (June 11, 2026), Boston Scientific FARADRIVE Steerable Sheath Recall: Risk of Air Embolism from Valve Damage (June 11, 2026), and Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall: Risk of Air Embolism (June 11, 2026).

How to tell if you have this one

Check for the product code ASDS-14F-075 and batch numbers listed: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835. The unique device identifier (UDI/DI) is 05415067036025.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your catheter matches the product code ASDS-14F-075 and the listed batch numbers.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Jun 12, 2023Firm started the recall
Jul 11, 2023FDA classified it Class I
Jul 19, 2023Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/57868-abbott-amplatzer-steerable-delivery-sheath-recall-air-embolism-risk">Abbott Amplatzer Steerable Delivery Sheath Recall: Air Embolism Risk (GovInfoNow)</a>

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-2110-2023 (June 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2110-2023 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.