Boston Scientific Recalls AngioJet Ultra 5000 A Console Foot Switches
Boston Scientific is recalling AngioJet Ultra 5000 A Console foot switches because they may stick during use, causing the device to operate continuously and undesirably.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device malfunction that leads to undesired continued operation, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Boston Scientific Corporation is recalling the AngioJet Ultra 5000 A Console foot switch (Material number 105650). The recall involves 3,402 units, with 2,626 units distributed in the United States and 786 units distributed outside the US.
The recall was initiated after the company received field reports that the foot switch may stick during use. This malfunction can result in the undesired continued operation of the device. The AngioJet Ultra 5000 A Console is a multiple-use device that controls the Thrombectomy Set, driving the pump and regulating fluid inflow and outflow.
The affected units are identified by specific serial number ranges, including U2000 - U4530, U5001 - U5233, U6001 - U6197, U6300 - U6374, U6376 - U6432, U8001 - U8276, U8500 - U8719, U8800 - U8829, and U8831 - U8869. The devices were distributed in the US and numerous international locations. Users should check their serial numbers and contact Boston Scientific for instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Serial number ranges:U2000 - U4530 U5001 - U5233
- U6001 - U6197
- U6300 - U6374
- U6376 - U6432
- U8001 - U8276
- U8500 - U8719
- U8800 - U8829
- U8831 - U8869.
Distribution
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