Amplatzer Steerable Delivery Sheath Recall
Abbott recalled the Amplatzer Steerable Delivery Sheath in July 2023 because the device may cause air bubbles to develop in patients’ bodies during cardiac procedures. The FDA classified this as a Class I recall because air emboli may lead to serious injuries, including stroke and death.
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Why Were Amplatzer Steerable Delivery Sheaths Recalled?
Abbott recalled Amplatzer Steerable Delivery Sheaths because of an increased risk of creating air bubbles, or air emboli, in patients who undergo procedures with this device. Air bubbles in the body can cause blood flow problems, low blood pressure or lack of oxygen. Doctors use the delivery sheaths in patients having heart procedures.
As of July 2023, Abbott received reports of 26 incidents and 16 injuries. The company is not aware of any deaths or permanent injuries related to the recalled Amplatzer Steerable Delivery Sheaths. According to Abbott’s medical device recall letter sent to medical providers, the incident rate was about 0.77%.
Which ASDS Devices Were Recalled?
As of July 2023, only one ASDS device model was included in the recall. Abbott recalled the ASDS-14F-075 model that was distributed from Oct. 4, 2022, to Feb. 22, 2023.
- 8597228
- 8598983
- 8601676
- 8611443
- 8619197
- 8627877
- 8650955
- 8663679
- 8795668
- 8815423
- 8824607
- 8830530
- 8846835
According to the recall notice, Abbott recalled 672 ASDS devices in the U.S. Two other recalled devices were distributed globally in Slovakia and the Czech Republic for a total of 675 units.
What Are the Risks of Using a Recalled Amplatzer Steerable Delivery Sheath?
The main risk of using a recalled Amplatzer Steerable Delivery Sheath involves the development of air emboli during cardiac procedures. In serious cases, air emboli may lead to stroke, death or other serious injuries.
People who have cardiac procedures with the recalled device have the highest risk of potential ASDS complications, according to the FDA’s recall notice.
- Death
- Fast or slow heartbeat
- Low blood oxygen
- Low blood pressure
- Stroke
- Sudden reduction in blood flow to the heart
Because of the risk of serious injuries, the FDA classified this recall as Class I. A Class I recall is the most serious type of recall, indicating the recalled device may cause serious injuries or death.
What to Do if You Were Affected by the ASDS Recall
If you are a patient who had a procedure with a recalled ASDS device and suffered complications, you can report these incidents to the FDA’s MedWatch Safety Information and Adverse Event Reporting program. You may also call 1-800-332-1088 for instructions on how to mail or fax a report form.
Lawyers are investigating any ASDS defects and are filing Amplatzer Steerable Delivery Sheath lawsuits on behalf of patients injured by the device. You may be able to seek compensation for your injuries or file a wrongful death lawsuit on behalf of a loved one who suffered a fatal injury.
Medical providers should return any unused ASDS devices to Abbott. Contact an Abbott representative for assistance. Abbott recommends using the fixed curve TorqVue 45° x 45° delivery system in place of the ASDS device.
Abbott’s Reaction to the ASDS Recall
Abbott reacted to the recall by sending medical device recall notices to customers in June 2023. The company explained the problems and risks of using the device along with instructions to return unused recalled devices.
The company stressed that this recall issue is specific to the homeostasis valve of the ASDS and does not affect the Amplatzer Amulet Left Atrial Appendage Occluder implant. Instructions for ASDS use indicate that putting the valve in the closed position “minimizes blood loss but does not prevent air ingress,” according to Abbott’s medical device recall letter.
The instructions also provided ways to reduce air entering the device, but the company still received reports of air emboli. This led to Abbott’s decision to recall the device.
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