Facility

KARDIUM Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007603855
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	8518 Glenlyon Parkway, Unit 155 Burnaby British Columbia, CA V5J0B6
Registration status	Active · expires 2026
Parent company	Kardium Inc. (owner-operator 10028366)
Brand names	Globe® Introducer

Activity by year

Recalls (1)

Devices registered here (1)

Catheter, Steerable
Product code DRA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1280

Recalls & enforcement

Class IITerminated2012-08-28
The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.

All facilities operated by Kardium Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “KARDIUM Inc. (FEI 3007603855) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007603855-kardium-inc/

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