CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Powerport Clearvue isp, 6F Chronoflex Catheter recalled
Bard Peripheral Vascular is recalling Powerport Clearvue isp, 6F Chronoflex Catheter, Intermediate Nautilus Delta Kit, distributed nationwide in the US. The recall was initiated on 25 Jun 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-2080-2019
- FDA event ID
- 82513
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 25 Jun 2018
- FDA classified
- 25 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 25 Jun 2018 | Recall initiated by company | |
| 25 Jul 2019 | Classified by FDA | +395 days |
| 31 Jul 2019 | 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
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Where it was distributed
US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
Nationwide AlabamaArizonaColoradoConnecticutFloridaIllinoisKansasMichiganOhioPennsylvaniaVirginiaWisconsinWest Virginia
Questions about this recall
Is Powerport Clearvue isp, 6F Chronoflex Catheter, Intermediate Nautilus Delta Kit recalled?
Yes. Bard Peripheral Vascular recalled Powerport Clearvue isp, 6F Chronoflex Catheter, Intermediate Nautilus Delta Kit on 25 Jun 2018. The recall is Class II and its status is Completed. Recall number Z-2080-2019.
Why was it recalled?
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Which lots are affected?
REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150
Where was it sold?
US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
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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| 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 |
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