Agency classClass IIOur severity:Severe FDA (Devices)·Z-0252-2018·Announced 2017-12-20

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

Navilyst Medical is recalling specific 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, and the hazard involves a structural defect in a medical device (handle detachment) that poses a risk of injury during use, meeting the criteria for a Severe rating.

Plain-English summary

Navilyst Medical, Inc. (NMI) is conducting a recall of specific Xcela 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 have the potential to detach from the sheath during use.

NMI has confirmed that the affected sheaths, identified by Greatbatch Model Number 10890-006, were included in packaged Xcela and BioFlo PICC Kits. The affected products include the Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895, specifically Lot 4903458. A total of 4,591 units are involved in this recall.

The products were distributed worldwide, including nationwide in the United States, as well as in Canada, Great Britain, the Netherlands, South Australia, and Spain. Healthcare providers and facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 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…
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — PICC Line
Hazard: structural-defect
injury-risk
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 4903458

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 →

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

See all →

Moderate
Xcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
Severe
AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
High
AngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
Moderate
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
Moderate
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27

Same hazard · structural defect