Alto Development Corp: Medical Device Recall in 2019 - (Recall #: Z-2098-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

Product Classification:

Class II

Date Initiated: June 21, 2019

Date Posted: August 7, 2019

Recall Number: Z-2098-2019

Event ID: 83285

Reason for Recall:

Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

Status: Terminated

Product Quantity: 351.5 Boxes

Code Information:

Lots 0715A or later

Distribution Pattern:

Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated