The Recall Desk
HighFDA (Devices)·Z-0564-2018·Announced 2018-02-21

Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner

Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.

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 high-risk medical device with a structural defect (torn liner) that 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

Kalila Medical is recalling 261 units of the Vado Bi-Directional Steerable Sheath 8.8F (REF SS8FMB74). The affected devices are sterile, prescription-only medical devices packaged in a lidded tray within a pouch and shelf carton. The recall covers Lot #0594 (expiration 1/19/2018) and Lot #0626 (expiration 04/23/2018).

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

The affected products were distributed 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 facilities should stop using the affected lots and contact Kalila Medical for instructions on return or replacement.

The recalled product

Product
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, 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
Affected units
261

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 #0594
  • exp. 1/19/2018
  • and Lot #0626
  • exp. 04/23/2018.

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 →

Related recalls

Same manufacturer · Kalila Medical

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Same hazard · structural defect

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