FDA Medical Device Recalls (openFDA)
Alto Development Corp: 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.
- Recall number
- Z-2098-2019
- Recalling firm
- Alto Development Corp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-06-21
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- 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.
- Root cause
- Labeling Change Control
- Action
- A&E Medical Corp issued on June 21, 2019 a Product Notice sent to customers who received M-21 pacing wires with Revision IFU advising customer of the change in instructions and providing a copy of the updated IFU for inclusion into any remaining inventory. Customers to confirm receipt of the notification and the results of inventory review by completing the attached Acknowledgement Form and emailing it to the address indicated on the form. Questions regarding this notification, please contact your A&E Medical Sales Representative or A&E Customer Service (800-323-4035
- Quantity
- 351.5 Boxes
- Distribution
- Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.
- Lot, serial or model codes
- Lots 0715A or later
- 510(k) numbers
- ["K803086"]
- PMA numbers
- not on file
- Product code
- LDF
- Firm FEI
- 2242056
- Firm city
- Wall Township
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28