Abbott Vascular Recalls RX Accunet Embolic Protection System Lots
Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System because the peel-away sheath may be difficult to remove due to higher than normal wall thickness.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that could impact patient safety during a procedure, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System (RX Accunet EPS). The device is indicated for use as a guide wire and embolic protection system. The recall affects 1,253 units, with 962 units distributed in the United States and Puerto Rico.
The recall was initiated because Abbott Vascular discovered that the identified lots may exhibit difficult removal of the peel-away sheath due to higher than normal wall thickness. The affected part numbers are 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, and 1011651-55.
The affected lot numbers are 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, and 1093061. The product was distributed worldwide, including the United States (nationwide), Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
The recalled product
- Product
- Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection…
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
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 (20)
- Lot Number: 1081061
- 1082561
- 1091361
- 1080561
- 1081761
- 1090261
- 1091561
- 1100461
- 1080361
- 1081661
- 1090161
- 1090861
- 1092361
- 1080861
- 1082661
- 1100761
- 1092861
- 1082461
- 1081161
- 1082261
Distribution
Distributed nationwide across the United States.
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