Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 to patients, 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 conducting a recall of Xcela PICC Kits with PASV, BioFlo PICC Kits 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 handles on the affected introducer sheaths (Model Number 10890-006) have the potential to detach from the sheath during use.
NMI has confirmed that the affected Greatbatch sheaths were included in the packaged Xcela and BioFlo PICC Kits. The recall covers 4,591 units in total. The affected products were distributed worldwide, including the United States (nationwide), Canada, Great Britain, the Netherlands, South Australia, and Spain.
The Xcela and BioFlo PICC Kits are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, and nutrients, as well as blood sampling and power injection of contrast media. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Kits
- 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 4908974
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.
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