Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires a minimum severity score of 4 (Severe) per the rubric. The source reports a 0.77% incidence rate of observed or potential air embolism, a serious complication during cardiac catheter procedures.
Plain-English summary
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), Model REF ASDS-14F-075, a percutaneous catheter used in cardiac procedures. The device carries FDA Class I classification, the highest risk designation.
The recall is based on a reported incidence rate of 0.77% related to observed or potential air embolism during procedures using this device. Air embolism is a serious complication that can occur during cardiac catheter procedures.
The recall affects 675 units distributed worldwide, including the United States, Slovakia, and the Czech Republic.
The recalled product
- Product
- Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
- Manufacturer
- Abbott
- Hazard
- Affected units
- 675
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- UDI/DI 05415067036025
- Batch Numbers: 8597228
- 8598983
- 8601676
- 8611443
- 8619197
- 8627877
- 8650955
- 8663679
- 8795668
- 8815423
- 8824607
- 8830530
- 8846835
Distribution
Distributed nationwide across the United States.
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