Agency classClass IIOur severity:High FDA (Devices)·Z-0563-2018·Announced 2018-02-21

Kalila Medical Recalls Vado Steerable Sheaths Due to Torn Liner

Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.

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 is classified as FDA Class II, and the defect involves a structural integrity issue (torn liner) in a sterile medical device. While no specific injuries are reported in the text, the risk of harm from a compromised sterile barrier or device integrity in a medical procedure warrants a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Kalila Medical is recalling 99 units of the Vado Steerable Sheath 8.8F (REF SS8FMU67). The devices are sterile, prescription-only medical instruments packaged in a lidded tray within a pouch and shelf carton. The recall involves Lot #0559 (exp. 10/9/2018) and Lot #0571 (exp. 10/19/2018).

The recall was initiated after internal product testing detected torn sheath liner material at the proximal end of the device. The company states that this defect may be the result of damage incurred during the manufacturing process.

Distribution of the affected units was made to the District of Columbia, Florida, Georgia, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, South Carolina, and Virginia. There was also military and government distribution, but no foreign distribution. Healthcare providers and patients should stop using these specific lots and contact Kalila Medical for further instructions.

The recalled product

Product: Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Manufacturer: Kalila Medical
Category: Medical Device — Interventional Cardiology
Hazard: structural-defect
sterility-compromise
Affected units: 99

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 (4)

Lot #0559
exp. 10/9/2018
and Lot #0571
exp. 10/19/2018.

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 2 recalled by Kalila Medical 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 2 products in this recall →

Same manufacturer · Kalila Medical

See all →

High
Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner
FDA (Devices) · 2018-02-21

Same hazard · structural defect