Z-0511-2019Class II

Multi-Track Angiographic Catheter (MMTA)

Name: Z-0511-2019 Multi-Track Angiographic Catheter (MMTA)
Creator: Numed Inc
Published: 2018-10-17
License: https://open.fda.gov/license/

Numed Inc / initiated 2018-10-17 / Terminated / root cause: labeling and UDI

FDA source

Numed Inc began a recall of Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular... on 2018-10-17. FDA classified it as Class II and gives the reason as "Instructions for Use booklets were not included on the outer pouch". 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-0511-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Posted: 2018-11-28
Terminated: 2019-01-28
Recalling firm: Numed Inc
Product: Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Instructions for Use booklets were not included on the outer pouch
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: NuMED issued recall notification letter and response form on 10/17/2018 via email to the one distributor and followed up by a hard copy of the letter and response form sent via UPS Next Day Air. The letter identified the affected product, problem and actions to be taken. The customer was instructed to return affected product..
Quantity in commerce: 100 units
Distribution: US distribution in the state of PA
Product codes and lots: Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0511-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28
Z-0511-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28

Product code DQO

K952984Class IIMap Multitrack Angiographic Catheter (4F)Map Medical Equipment, Inc. / cleared 1996-01-29

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)