CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
BardPort M.R.I recalled by Bard Peripheral Vascular
Bard Peripheral Vascular is recalling BardPort M.R.I, distributed nationwide in the US. The recall was initiated on 1 Oct 2019 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-1576-2020
- FDA event ID
- 84914
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2019
- FDA classified
- 26 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 26 Mar 2020 | Classified by FDA | +177 days |
| 1 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Product as listed by the FDA
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is BardPort M.R.I recalled?
Yes. Bard Peripheral Vascular recalled BardPort M.R.I on 1 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-1576-2020.
Why was it recalled?
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Which lots are affected?
Lot # RECU2404, RECU1067, RECR1439, RECT0078
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
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.
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