Abbott Amplatzer Steerable Delivery Sheath instructions for use updated
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving an instruction-for-use update. No illnesses, injuries, or hospitalizations are reported in the source. The recall appears to be precautionary or corrective in nature, addressing a potential hazard through clarified instructions.
Plain-English summary
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath, Model ASDS-14F-075, that were distributed outside the United States. The affected batch numbers are: 7963817, 7976534, 7981029, 7990340, 8008111, 8010056, 8025120, 8102214, 8106240, 8234848, 8274323, and 8277741.
The instructions for use for this device have been updated. The specific reason for the instruction update and the nature of the hazard addressed are not detailed in this recall notice.
Patients and healthcare providers who have used or may use this device should review the updated instructions. For questions or concerns regarding this recall, contact Abbott directly.
The recalled product
- Product
- Amplatzer Steerable Delivery Sheath
- Manufacturer
- Abbott
- Affected units
- 529
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 (1)
- Model ASDS-14F-075
Distribution
Distribution scope not specified by the agency.
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