Reported Dec 25, 2019 · Terminated
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- AngioJet
- Ultra Consoles-Thrombectomy System UPNProduct Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console
105650-001D105650-001H105650-001R105650-001Z105650-002R105650-004H105650-004R105650-007R105650-009R105650-024H105650-024Z105650-025105650-025H105650-025R105650-026R
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published 105650-002R08714729890638U2704 105650-004H 08714729890683¿ U3788 105650-004H 08714729890683¿ U5073 105650-004R08714729890690U3192 105650-007R08714729890782U3179 105650-007R08714729890782U3191 105650-007R08714729890782U3396 105650-007R08714729890782U4108 105650-007R08714729890782U4224 105650-009R08714729890843U3371 105650-024H08714729891284U4112 105650-024Z 08714729892656¿ U8808 105650-025 08714729891307¿ U8047 105650-025H08714729891314U8511 105650-025R 08714729891321¿ U3278 105650-025R 08714729891321¿ U3858 105650-025R 08714729891321¿ U8041 105650-025R 08714729891321¿ U8049 105650-025R 08714729891321¿ U8050 105650-025R 08714729891321¿ U8052 105650-025R 08714729891321¿ U8054 105650-025R 08714729891321¿ U8059 105650-025R 08714729891321¿ U8060 105650-025R 08714729891321¿ U8062 105650-025R 08714729891321¿ U8073 105650-025R 08714729891321¿ U8074 105650-025R 08714729891321¿ U8075 105650-025R 08714729891321¿ U8080 105650-025R 08714729891321¿ U8081 105650-025R 08714729891321¿ U8089 105650-025R 08714729891321¿ U8148 105650-025R 08714729891321¿ U8153 105650-025R 08714729891321¿ U8195 105650-025R 08714729891321¿ U8197 105650-025R 08714729891321¿ U8214 105650-025R 08714729891321¿ U8560 105650-025R 08714729891321¿ U8564 105650-025R 08714729891321¿ U8594 105650-025R 08714729891321¿ U8631 105650-025R 08714729891321¿ U8802 105650-025R 08714729891321¿ U8803 105650-025R 08714729891321¿ U8804 105650-025R 08714729891321¿ U8835 105650-025R 08714729891321¿ U8854 105650-025R 08714729891321¿ U8872 105650-025R 08714729891321¿ U8879 105650-025R 08714729891321¿ U8883 105650-025R 08714729891321¿ U8885 105650-025R 08714729891321¿ U8907 105650-025R 08714729891321¿ U8919 105650-025R 08714729891321¿ U8942 105650-025R 08714729891321¿ U8980 105650-025R 08714729891321¿ U8985 105650-025R 08714729891321¿ U8993 105650-025R 08714729891321¿ U9047 105650-025R 08714729891321¿ U9048 105650-025R 08714729891321¿ U9078 105650-026R 08714729891352¿ U8260 - Amount recalled
- 169 units ((OUS: 44 US: 125)
Where it was sold
- Nationwide
Why it was recalled
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
This product could cause temporary or reversible health problems — stop using it.
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