Boston Scientific Corporation: 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

Is my product affected?

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 allows for percutaneous removal of thrombus

• UPC 08714729892182
• UPC 08714729890591
• UPC 08714729890607
• UPC 08714729892199
• UPC 08714729890638
• UPC 08714729890683
• UPC 08714729890690
• UPC 08714729890782
• UPC 08714729890843
• UPC 08714729891284
• UPC 08714729892656
• UPC 08714729891307
• UPC 08714729891314
• UPC 08714729891321
• UPC 08714729891352

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling AngioJet Ultra Consoles-Thrombectomy System units because they were shipped to customers without the required Operator's Manual (Directions for Use). A total of 169 units were affected by this issue, with 125 units distributed in the United States and 44 units distributed outside the United States, including Canada.

The recall covers multiple console models identified by specific UPN codes and serial numbers. The source document does not specify what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.

Details from the source

Reason for recall: Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual. Distribution: Worldwide distribution - US Nationwide distribution and country of Canada. Quantity: 169 units ((OUS: 44 US: 125) Lot/code info: UPN GTN SERIAL NUMBER 105650-001D 08714729892182¿ U2541 105650-001D 08714729892182¿ U2893 105650-001D 08714729892182¿ U3139 105650-001D 08714729892182¿ U4146 105650-001D 08714729892182¿ U5058 105650-001D 08714729892182¿ U5136 105650-001H 08714729890591¿ U2259 105650-001H 08714729890591¿ U2262 105650-001H 08714729890591¿ U2379 105650-001H 08714729890591¿ U2552 105650-001H 08714729890591¿ U2613 105650-001H 08714729890591¿ U2851 105650-001H 08714729890591¿ U2976 105650-001H 08714729890591¿ U3460 105650-001H 08714729890591¿ U3535 105650-001H 08714729890591¿ U3611 105650-001H 08714729890591¿ U3731 105650-001H 08714729890591¿ U3819 105650-001H 08714729890591¿ U3939 105650-001H 08714729890591¿ U6400 105650-001R 08714729890607¿ U2003 105650-001R 08714729890607¿ U2004 105650-001R 08714729890607¿ U2007 105650-001R 08714729890607¿ U2021 105650-001R 08714729890607¿ U2023 105650-001R 08714729890607¿ U2025 105650-001R 08714729890607¿ U2042 105650-001R 08714729890607¿ U2052 105650-001R 08714729890607¿ U2054 105650-001R 08714729890607¿ U2056 105650-001R 08714729890607¿ U2066 105650-001R 08714729890607¿ U2080 105650-001R 08714729890607¿ U2092 105650-001R 08714729890607¿ U2094 105650-001R 08714729890607¿ U2117 105650-001R 08714729890607¿ U2133 105650-001R 08714729890607¿ U2149 105650-001R 08714729890607¿ U2185 105650-001R 08714729890607¿ U2192 105650-001R 08714729890607¿ U2193 105650-001R 08714729890607¿ U2199 105650-001R 08714729890607¿ U2206 105650-001R 08714729890607¿ U2208 105650-001R 0871

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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