CLASS II Device recall · Reported 5 Dec 2018 · FDA Enforcement Report
Multi-Track Angiographic Catheter (MMTA) Product recalled by Numed
Numed is recalling Multi-Track Angiographic Catheter (MMTA), distributed in Pennsylvania. The recall was initiated on 17 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0511-2019
- FDA event ID
- 81460
- Recalling firm
- Numed, Hopkinton, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2018
- FDA classified
- 28 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Oct 2018 | Recall initiated by company | |
| 28 Nov 2018 | Classified by FDA | +42 days |
| 5 Dec 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instructions for Use booklets were not included on the outer pouch
Product as listed by the FDA
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.
Where it was distributed
US distribution in the state of PA
Questions about this recall
Why was it recalled?
Instructions for Use booklets were not included on the outer pouch
Which lots are affected?
Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861
Where was it sold?
US distribution in the state of PA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81460This product is part of a recall event; the main page for the event is Multi-Track Angiographic Catheter (MMTA) Product recalled by Numed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Multi-Track Angiographic Catheter (MMTA) Product recalled by Numed | Numed | Other | PA |
More recalls from Numed
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BIB Balloon in Balloon Dilatation Catheter recalled by Numed | Numed | Other | PA |
| Device | CLASS II | Multi-Track Angiographic Catheter (MMTA) Product recalled by Numed | Numed | Other | PA |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |