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Device Recall Bard
Model / Serial
Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units). Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
CA, MA
Product Description
Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
Manufacturer
Enpath Medical, Inc.
1 Event
Recall of Device Recall Bard
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Manufacturer
Enpath Medical, Inc.
Manufacturer Address
Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
Source
USFDA
81 devices with a similar name
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Device Recall BARD DORADO
Model / Serial
LOT NUMBERS: 93FT0152
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712
Manufacturer
Bard Peripheral Vascular Inc
Device Recall BARD DORADO
Model / Serial
LOT NUMBERS: 93DT0146, 93DT0175, 93IT0211, 93IT0211
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715
Manufacturer
Bard Peripheral Vascular Inc
Device Recall Bard PEG
Model / Serial
Lots: 43FQA076, 43IQA096, 43KQA098, HURD1299, HURE3445 , HURI0365, HUSA0502, HUSC0154.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" , REF 003028, 28F, Sterile.
Manufacturer
C.R. Bard Access Systems, Inc
Device Recall Bard Deluxe Guidewire PEG
Model / Serial
Lots: HURL0217, HUSB0186, HUSC0157, HUSD0382, HUSD2075.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F.
Manufacturer
C.R. Bard Access Systems, Inc
Device Recall Bard Deluxe Guidewire PEG
Model / Serial
Lots: 43DQA112, 43EQA079, 43EQA080, 43FQA074, 43FQA097, 43GQA075, 43GQA076, 43GQA194, 43HQA079, 43HQA080, 43IQA180, 43KQA114, 43KQA115, 43LQA107.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F.
Manufacturer
C.R. Bard Access Systems, Inc
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