CLASS I ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report
Amplatzer Steerable Delivery Sheath (ASDS) recalled by Abbott
Abbott is recalling Abbott Amplatzer Steerable Delivery Sheath (ASDS), distributed nationwide in the US. The recall was initiated on 12 Jun 2023 and the FDA has classified it as Class I.
Check your package
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-2110-2023
- FDA event ID
- 92502
- Recalling firm
- Abbott, Plymouth, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jun 2023
- FDA classified
- 11 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 12 Jun 2023 | Recall initiated by company | |
| 11 Jul 2023 | Classified by FDA | +29 days |
| 19 Jul 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Questions about this recall
Is Amplatzer Steerable Delivery Sheath (ASDS) recalled?
Yes. Abbott recalled Amplatzer Steerable Delivery Sheath (ASDS) on 12 Jun 2023. The recall is Class I and its status is Ongoing. Recall number Z-2110-2023.
Why was it recalled?
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.
Which lots are affected?
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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