The Recall Desk
HighFDA (Devices)·Z-0249-2018·Announced 2017-12-20

Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for component detachment during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Navilyst Medical, Inc. (NMI) is recalling specific Xcela and BioFlo PICC kits to the end-user level. The recall is based on information from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer included in these kits. Greatbatch Medical determined that the handles on the affected introducers have the potential to detach from the sheath during use.

NMI has confirmed that the affected sheaths, identified as Greatbatch Model Number 10890-006, were included in the packaged Xcela and BioFlo PICC kits. The affected products include the Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology. These devices are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.

The recall affects 4,591 units distributed worldwide, including the United States (nationwide), Canada, Great Britain, the Netherlands, South Australia, and Spain. The specific lot number is 4913255. Users should stop using the affected kits and contact Navilyst Medical or their healthcare provider for instructions on replacement or return.

The recalled product

Product
Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous s
Manufacturer
Angiodynamics Inc. (Navilyst Medical Inc.)
Category
Medical Device — PICC Lines
Hazard
Affected units
4,591

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 4913255

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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Same hazard · component detachment

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