Pump, Portable, Aspiration (Manual Or Powered)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-09-20Open, ClassifiedProcess control

  MINISCAV (tm) Vacuum Pump

  Inadequate documentation of acceptance activity

• 2018-09-07TerminatedNonconforming Material/Component

  Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

  The 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 wiring and resulting in loss of function or an inoperable unit under battery power.

• 2010-12-29TerminatedDevice Design

  Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

  The 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 damage the battery inside the device if the screw is over-tightened.

• 2010-06-07TerminatedOther

  MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case).

  Ohio 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 transport bag during use.

• 2010-06-07TerminatedOther

  NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.

  Ohio 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 transport bag during use.

• 2008-10-27TerminatedNonconforming Material/Component

  GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.

  External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.

• 2008-09-29TerminatedNonconforming Material/Component

  NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator

  Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.

• 2008-09-04TerminatedEmployee error

  Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)

  The 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 attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.

• 2008-08-06TerminatedLabeling mix-ups

  FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.

  Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.

• 2006-10-12TerminatedOther

  SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

  Faulty circuit board may short circuit and cause electric shock to operator