Boston Scientific Recalls AngioJet Ultra Consoles Missing Operator's Manuals
Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (missing manual) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Boston Scientific Corporation is recalling 169 units of the AngioJet Ultra Consoles-Thrombectomy System. The recall is due to a missing Directions for Use (DFU) issue, where consoles were shipped to customers without the required Operator's Manual.
The affected products include various models of the AngioJet Ultra Consoles, identified by specific UPNs and serial numbers. The system is used for percutaneous removal of thrombus in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits.
The recall covers units distributed worldwide, including nationwide distribution in the US and in Canada. A total of 169 units are affected, with 125 in the US and 44 outside the US. Customers should check their records for the specific serial numbers listed in the recall notice and contact Boston Scientific for further instructions.
The recalled product
- Product
- AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet…
- Manufacturer
- Boston Scientific Corporation
- Hazard
Distribution
Distributed nationwide across the United States.
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