Strata II, Delta, and CSF-Flow Control Valves and Shunts (2021-01-18)
- Starting date:
- January 18, 2021
- Posting date:
- February 5, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74921
Last updated: 2021-02-05
Affected Products
A. CSF-FLOW CONTROL VALVES
B. CSF-FLOW CONTROL SHUNTS
C. CSF-SHUNT ASSEMBLY SMALL
D. DELTA SHUNT ASSEMBLY
E. STRATA VALVE
F. STRATA II VALVE
G. Strata NSC Lumboperitoneal Shunt Kit
H. CSF Flow control Shunt- Delta Valve
I. STRATA BURR HOLE VALVE
J. STRATA NSC BURR HOLE VALVE
Reason
Potential for variation in radiopaque marking visibility under radiographic imaging for Medtronic adjustable and fixed-pressure valves that are used in the management of hydrocephalus. This issue does not impact the therapeutic pressure performance of these devices, however variation in radiopaque marking visibility post-implant may limit the ability to determine pressure settings and flow direction with radiographic imaging.
Affected products
A. CSF-FLOW CONTROL VALVES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
42314
42322
42324
42534
42544
42546
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. CSF-FLOW CONTROL SHUNTS
Lot or serial number
219278517
219374313
Model or catalog number
42414
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
C. CSF-SHUNT ASSEMBLY SMALL
Lot or serial number
219278874
Model or catalog number
46624
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
D. DELTA SHUNT ASSEMBLY
Lot or serial number
220400352
Model or catalog number
46822
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
E. STRATA VALVE
Lot or serial number
218609100
Model or catalog number
42355
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
F. STRATA II VALVE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
42856
42866
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
G. Strata NSC Lumboperitoneal Shunt Kit
Lot or serial number
219332743
219467665
220040131
220328424
Model or catalog number
44420
44421
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
H. CSF Flow control Shunt- Delta Valve
Lot or serial number
217344861
218721468
Model or catalog number
42813
42823
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
I. STRATA BURR HOLE VALVE
Lot or serial number
219309515
219815331
220314446
220393226
Model or catalog number
42836
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
J. STRATA NSC BURR HOLE VALVE
Lot or serial number
219467660
219467661
Model or catalog number
42335
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES