Motor, Drill, Pneumatic

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

• 2025-10-02Open, ClassifiedProcess control

  AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

  Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

• 2025-10-02Open, ClassifiedProcess control

  AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

  Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

• 2018-02-15TerminatedNo Marketing Application

  The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

  The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).

• 2016-06-09TerminatedComponent design/selection

  Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.

  Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the attachment end of the motor. There is a negligible possibility that the orange grease may leak from the attachment end of the motor and contaminate the surgical wound resulting in soft tissue inflammation.

• 2016-05-04TerminatedLabeling mix-ups

  Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

  Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

• 2014-06-25TerminatedProcess design

  ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-06-25TerminatedProcess design

  ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-06-25TerminatedProcess design

  ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-06-25TerminatedProcess design

  ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-01-09TerminatedComponent design/selection

  ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

  The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..