FDA Device Intelligence
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Pump, Portable, Aspiration (Manual Or Powered)

FDA product code BTA · Class 2 · General, Plastic Surgery

543
Registered devices
968
Adverse events
21
Recalls
159
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-08-23R A Medical ServicesInadequate documentation of acceptance activity
2021-11-16Ohio Medical CorporationIncrease in premature device failures
2020-12-02Medela AG Medical TechnologyIncorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
2018-08-14Ohio Medical CorporationThe care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wirin
2016-02-08MicroAire Surgical Instruments, LLCComplaints that the cannula bent/broke during surgery.
2010-11-08Ohio Medical CorporationThe D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may dam
2010-05-10Ohio Medical CorporationOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon tr
2010-05-10Ohio Medical CorporationOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon tr
2008-08-07Smith And Nephew, Inc. Wound Management DivisionExternal battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
2008-04-25Medtronic NeuromodulationThe Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attac

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.