CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report
Trocar catheter recalled by Atrium Medical
Atrium Medical is recalling Atrium Medical Trocar catheter, distributed in Puerto Rico. The recall was initiated on 26 Oct 2016 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-0579-2017
- FDA event ID
- 75347
- Recalling firm
- Atrium Medical, Hudson, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2016
- FDA classified
- 16 Nov 2016
- Reported
- 23 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 26 Oct 2016 | Recall initiated by company | |
| 16 Nov 2016 | Classified by FDA | +21 days |
| 23 Nov 2016 | 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
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Where it was distributed
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
Questions about this recall
Is Trocar catheter recalled?
Yes. Atrium Medical recalled Trocar catheter on 26 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0579-2017.
Why was it recalled?
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Which lots are affected?
All lot codes
Where was it sold?
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Atrium Medical
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | iCast Covered Stent, 6MMx16MMx120CM recalled by Atrium Medical | Atrium Medical | Other | Nationwide |
| Device | CLASS II | Advanta Vxt, 1gds, Nh, Str-sw recalled by Atrium Medical | Atrium Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |