Z-1401-2017Class II

AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a...

Name: Z-1401-2017 AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a...
Creator: Boston Scientific Corporation
Published: 2017-01-31
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-01-31 / Terminated

FDA source

Boston Scientific Corporation began a recall of AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy... on 2017-01-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1401-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-31
Posted: 2017-03-03
Terminated: 2019-04-22
Recalling firm: Boston Scientific Corporation
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.
Product code: MCX Catheter, Coronary, Atherectomy
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.
FDA root cause: Under Investigation by firm
Action: Field notification letters were sent on January 31, 2017 by certified mail to affected customers. Letters request that Users follow the operator's manual for service and maintenance and if they notice that the foot switch is sticking to discontinue use and contact BSC Technical support at 1 800-949-6708 or [email protected].
Quantity in commerce: 3402 units; 2626 in US; 786 units OUS
Distribution: US and Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Denmark, Dominican Rep., Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, Russian Fed. ,Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, United Arab Emir., Venezuela, Virgin Islands, W.Bank/Gaza Strip
Product codes and lots: Serial number ranges:U2000 - U4530 U5001 - U5233; U6001 - U6197; U6300 - U6374 ; U6376 - U6432; U8001 - U8276; U8500 - U8719; U8800 - U8829; U8831 - U8869.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1401-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1401-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code MCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)