IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ Cryoablation Needles and Prostate Cryoablation Kits (2020-11-18)
- Starting date:
- November 18, 2020
- Posting date:
- December 4, 2020
- 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-74477
Last updated: 2020-12-03
Affected Products
A. PRESICE CRYOSURGICAL SYSTEM - ICESEED PREMIUM PROSTATE KIT
B. PRESICE CRYOSURGICAL SYSTEM - ICEROD PROSTATE KIT
C. PRESICE CRYOSURGICAL SYSTEM - INDIVIDUAL ICEROD NEEDLE
D. SEEDNET - ICESEED NEEDLES
E. SEEDNET - ICESEED 90 DEG
F. ICEROD PLUS CRYOABLATION NEEDLE
G. ICEEDGE CRYOABLATION NEEDLE
H. ICEROD CX CRYOABLATION NEEDLE
I. ICESPHERE CRYOABLATION NEEDLE
J. ICEPEARL CRYOABLATION NEEDLE
K. ICEFORCE CRYOABLATION NEEDLE
L. ICESPHERE 1.5 CX 90 CRYOABLATION NEEDLE
Reason
Gas leaks from the needle shaft that determined some users of these devices are not adhering to the preparation technique described within the products' Instructions for Use (IFU), which ensures needle integrity of the entire needle shaft. This advisory is intended to reinforce existing instructions within the IFU directing users to fully submerge the entire needle shaft in sterile water or saline prior to the patient being anesthetized to identify a possible defective needle, therefore reducing the likelihood of patient harm from a gas shaft leak during the procedure.
Affected products
A. PRESICE CRYOSURGICAL SYSTEM - ICESEED PREMIUM PROSTATE KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR4518
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
B. PRESICE CRYOSURGICAL SYSTEM - ICEROD PROSTATE KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR4070
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
C. PRESICE CRYOSURGICAL SYSTEM - INDIVIDUAL ICEROD NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR4009
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
D. SEEDNET - ICESEED NEEDLES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3201
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
E. SEEDNET - ICESEED 90 DEG
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3202
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
F. ICEROD PLUS CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3508
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
G. ICEEDGE CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3506
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
H. ICEROD CX CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3533
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
I. ICESPHERE CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3558
FPRPR3560
FPRPR3561
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
J. ICEPEARL CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3601
FPRPR3603
FPRPR3617
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
K. ICEFORCE CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3602
FPRPR3618
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL
L. ICESPHERE 1.5 CX 90 CRYOABLATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FPRPR3573
Companies
- Manufacturer
-
Galil Medical Ltd.
TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224
YOKNEAM
2069203
ISRAEL