Z-2098-2019Class II

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)...

Name: Z-2098-2019 A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)...
Creator: Alto Development Corp
Published: 2019-06-21
License: https://open.fda.gov/license/

Alto Development Corp / initiated 2019-06-21 / Terminated / root cause: labeling and UDI

FDA source

Alto Development Corp began a recall of 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... on 2019-06-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2098-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-21
Posted: 2019-07-29
Terminated: 2020-05-13
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.
Product code: LDF Electrode, Pacemaker, Temporary
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 351.5 Boxes
Distribution: Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.
Product codes and lots: Lots 0715A or later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2098-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-29

Product code LDF

K803086Class IIMyowire-Atemporary Cardiac Pacing WireCraig & Craig, Inc. / cleared 1981-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)