AngioJet¿ Ultra 5000 A Console:Foot Switch Material number — Class II medical device recall Z-1401-2017
Terminated recall by Boston Scientific Corporation, reported 2017-03-15, distributed in PR. Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking
| Recall number | Z-1401-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Fremont, CA, United States |
| Recall initiated | 2017-01-31 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-04-22 |
| Distributed | PR |
| Countries outside the US | AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CR, CY, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IQ, IT, JO, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PH, PL, PT, SA, SE, SG, SI, TH, TR, TT, TW, VE, ZA |
| Serial numbers | U4530, U5001, U5233, U6001, U6197, U6300, U6374, U6376, U6432, U8001, U8276, U8500, U8719, U8800, U8829, U8831, U8869 |
Product
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings.
Reason for recall
Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1401-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.