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.
What this means for you
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 system.
- 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.
Related recalls
Same manufacturer · Abbott Vascular
See all →- HighMitraClip Clip Delivery System Recalled for Locking Malfunctions
FDA (Devices) · 2022-10-26
- HighAbbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
FDA (Devices) · 2022-10-26
- HighMitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
FDA (Devices) · 2022-10-26
- SevereDragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk
FDA (Devices) · 2022-05-25
- HighAbbott Vascular 20/30 Indeflator Recalled for Leaks and Connection Failures
FDA (Devices) · 2022-04-20
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22