The Recall Desk
SevereFDA (Devices)·Z-0241-2018·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 included Greatbatch introducer sheaths have handles that may detach during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component detaching during use of an invasive medical device, which presents a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Navilyst Medical, Inc. (NMI) is conducting a recall of Xcela PICC with PASV, BioFlo PICC with PASV, and BioFlo PICC kits to the end-user level. The recall is based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer included in these kits.

Greatbatch Medical determined that the specific introducer sheaths (Model Number 10890-006) have the potential for the handles to detach from the sheath during use. NMI has confirmed that these affected sheaths were included in the packaged Xcela and BioFlo PICC kits.

The recall affects 4,591 units in total, distributed worldwide including the United States, Canada, Great Britain, the Netherlands, South Australia, and Spain. The affected product is identified by Lot 4904007. Users should stop using the affected kits and contact the manufacturer for instructions.

The recalled product

Product
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 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 syst
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 4904007

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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